The Dukal Isolation Gown made from PP material for Green and SMS material for all the remaining colors is a must-have product for healthcare professionals and workers in various industries. Designed to provide superior protection and comfort, this isolation gown is an essential part of any safety protocol. Featuring knit cuffs with tie back, this gown ensures a secure and comfortable fit. The cuffs not only provide a snug fit but also help prevent exposure to hazardous materials or fluids. The gown is designed with the wearer's comfort in mind, allowing them to move freely during tasks. One of the key features of this isolation gown is that it is not made with natural rubber latex. This makes it safe for individuals with latex allergies, minimizing the risk of allergic reactions. The non-sterile design allows for easy and efficient use in various settings. The Dukal Isolation Gown comes in a regular size, suitable for most users. The teal/green color adds a touch of style to the functionality, making it visually appealing. With a weight of 7.49572 lbs, it is lightweight and easy to carry. The packaging of this isolation gown is designed for convenience and efficiency. Each pack contains 10 gowns, allowing for easy distribution and storage. The inner packaging also includes 10 gowns, and each case contains 5 packs, totaling 50 gowns. The inner packaging barcode UGI-6705 ensures easy tracking and organization. When it comes to safety and protection, choose the Dukal Isolation Gown made from PP material. With its durable construction and thoughtful design, it provides reliable protection without compromising on comfort. Order yours today and experience the difference. Key Features/Benefits: Knit cuffs with tie back for a secure and comfortable fit. Not made with natural rubber latex, suitable for individuals with latex allergies. Brand Name Unipack Size Regular Color Multiple Sterile No Weight 7.49572 lbs Packaging: Packaging 10/BG Inner Packaging 10/BG Case Packaging 10/BG, 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode Multiple

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Over-the-head protective cover gown with thumbloop Provides enhanced fluid protection Tear away design enables gown to be removed quickly Open back style provides comfortable fit Gown material meets AAMI PB70 Standard for level 2 Attributes Brand Name Dukal Size XL Color Blue Material Polyethylene Film Sterile No Weight 9.25942 lbs Packaging Packaging 15/BG, 5 BG/CS Inner Packaging 15/BG Case Packaging 5 BG/CS Total Case Quantity 75 Inner Packaging Barcode (01)10665973027972 Case Packaging Barcode (01)20665973027979

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Meets AAMI Level 2 requirements for fluid protection Proprietary over-the-head design with easy tear away removal Elastic wrist with thumbloop to provide a more secure fit under gloves Used in low risk fluid situation Attributes Brand Name Dukal Size Universal Color Yellow Material SMS Sterile No Weight 14.33 lbs Packaging Packaging 10/BG, 10 BG/CS Inner Packaging 10/BG Case Packaging 10/CS Total Case Quantity 100 Inner Packaging Barcode (01)10665973028344 Case Packaging Barcode (01)20665973028341

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Meets AAMI Level 1 and 2 requirements for fluid protection Provides a slight barrier against a small amount of fluid penetration Elastic wrist with thumb loop to provide a more secure fit under gloves Tape tab neck with waist ties Used in minimal-risk situations Attributes Brand Name Dukal Color Yellow Material SMS Sterile No Weight 13.22774 lbs Packaging Packaging 10/BG, 10 BG/CS Inner Packaging 10/BG Case Packaging 10 BG/CS Total Case Quantity 100 Inner Packaging Barcode (01)10665973027996 Case Packaging Barcode (01)20665973027993

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Made of quality multi-layer SMS material for enhanced protection Features elastic wrists with waist tie and neck closures to provide full coverage Attributes Brand Name Dukal Size Universal Color Yellow Material SMS Sterile No Weight 11.9 lbs Packaging Packaging 10/BG, 10 BG/CS Inner Packaging 10/BG Case Packaging 10/CS Total Case Quantity 100 Inner Packaging Barcode (01)10665973028306 Case Packaging Barcode (01)20665973028303

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Made of spunbond polypropylene with a polyethylene coating Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size Universal Color Blue Material SPP+PE Sterile No Weight 9.9208 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973003198 Case Packaging Barcode (01)20665973003195

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Made of high quality spunbonded polypropylene Poly coated for enhanced fluid protection Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size Universal Color Yellow Material SPP+PE Sterile No Weight 9.9208 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973003181 Case Packaging Barcode (01)20665973003188

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Over-the-head protective cover gown with thumbloop Provides enhanced fluid protection Tear away design enables gown to be removed quickly Open back style provides comfortable fit Gown material meets AAMI PB70 Standard for level 2 Attributes Brand Name Dukal Size Regular Color Blue Material Polyethylene Film Sterile No Weight 11.02311 lbs Packaging Packaging 15/BG, 5 BG/CS Inner Packaging 15/BG Case Packaging 5 BG/CS Total Case Quantity 75 Inner Packaging Barcode (01)10665973027965 Case Packaging Barcode (01)20665973027962

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Made of spunbonded polypropylene Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size XL Color Yellow Material Spunbond Polypropylene Sterile No Weight 7.05479 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973013081 Case Packaging Barcode (01)20665973013088

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Made of spunbonded polypropylene Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size One-Size Color Blue Material Spunbond Polypropylene Sterile No Weight 9.25942 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973003167 Case Packaging Barcode (01)20665973003164

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Made of quality spunbonded polypropylene Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size One-Size Color Yellow Material Spunbond Polypropylene Sterile No Weight 6.61387 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973003143 Case Packaging Barcode (01)20665973003140

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All gowns are made of high quality spunbonded polypropylene Isolation gowns are available in 3 colors to allow easy detection between departments or functions Each gown features elastic cuffs with waist and neck tie closures Attributes Brand Name Dukal Size One-Size Color Yellow Material Spunbond Polypropylene Sterile No Weight 4.85017 lbs Packaging Packaging 10/BG, 5 BG/CS Inner Packaging 10/BG Case Packaging 5 BG/CS Total Case Quantity 50 Inner Packaging Barcode (01)10665973003174 Case Packaging Barcode (01)20665973003171

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Isolation Gowns from MARK3 are strong, lightweight and breathable. They provide protection and moisture resistance in healthcare settings. Full length cut and cool and comfortable to wear.Contains: 10 gowns per pack Product Specifications MARK3 Isolation Gown Tie-Back Medium Knit Cuff Sky Blue 10/pk.  Isolation Gowns from MARK3 are strong, lightweight and breathable. They provide protection and moisture resistance in healthcare settings. Full length cut and cool and comfortable to wear.

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Protective Procedure Gown McKesson One Size Fits Most Blue NonSterile AAMI Level 2 Disposable McKesson Over-the-Head Isolation Gowns One Size Fits Most-Packaged: 75 Per Case Open-back design allows for increased airflow and comfort Easy-to-don/doff design features closed-loop neck allowing user to slip the gown over the head and tear off quickly and conveniently Long sleeves feature integrated thumb loops to maintain full protection from fluids and infectious material through the wrist and makes donning gloves easy Waist ties secure gown on user to maintain level 2 protection in critical zones Tested and classified as AAMI Level 2 in the critical zones per AAMI Standard PB70:2012 Universal, light blue design to fit most users and implied procedural use for convenience Made from soft, fluid-resistant polyethylene to help ensure protection and comfort Designed to help protect healthcare professionals during medical procedures Not made with natural rubber latex to provide a hypoallergenic PPE solution Not intended to be used in a surgical setting or in the presence of high intensity heat source or flammable gas

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The Dynarex Isolation Gown Fluid Resistant Universal, Yellow 50 pack offers an unbeatable combination of affordability, comfort, and reliability for all your protective needs. With sturdy sewn seams that provide unparalleled strength and durability, these isolation gowns are built to last and offer maximum protection in various environments. Designed for healthcare professionals and laboratory technicians, these gowns ensure your safety and well-being. The fluid-resistant design shields you from spills and splashes, giving you peace of mind while working. Its latex-free material makes it suitable for individuals with latex allergies, ensuring comfort for everyone. Featuring extra-long waist ties, these gowns allow for easy and secure fastening in the front, ensuring a snug fit that stays in place even during extended wear. The elastic cuffs provide added convenience, preventing any potential exposure to hazards. With 50 yellow isolation gowns in each pack, you'll have an ample supply to meet your needs. Whether you're a healthcare facility, a laboratory, or any professional requiring reliable protective gear, this pack has you covered. Key Features/Benefits: Economical, comfortable, and reliable protection Sewn seams for superior strength These Dynarex Isolation Gowns are an investment in your safety and the safety of those around you. The universal size ensures a great fit for most individuals, eliminating any worries about finding the right size. Specifications: Color: Yellow Quantity: 50 gowns per pack Size: Universal Don't compromise on safety and quality. Choose the Dynarex Isolation Gown Fluid Resistant Universal, Yellow 50 pack and experience the ultimate protection that doesn't break the bank.

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Balanced Performance: Thanks to their optimal thickness levels, ENCORE Perry Style 42 PF latex surgical gloves ideally combine the glove wearer’s need for barrier protection and tactile sensitivity, offering better instrument ‘feel’ during surgery Improved Comfort: The proprietary anatomic formers used in the design of these ENCORE gloves ensure a comfortable fit and minimal hand fatigue with sustained use Effortless Donning And Doffing: These latex surgical gloves’ internal surface has a special polymer coating, making them swift and easy to don Chemo-Tested: They are also tested for use with chemotherapy drugs in accordance with ASTM D6978 Key Features And Benefits: Optimal Glove Thickness: A balance of protection and tactile sensitivity Anatomic Design: Enhanced comfort and reduced hand muscle effort Polymer-Coated Internal Surface: Quick and easy donning Recommended For: Brief, low-risk examination procedures Sterile procedures in the O.R. Use as an outer glove when double gloving Sterile procedures outside of the O.R. Primary Industries: Healthcare Product Details: Packaging: Size Code 5.5 5711100PF 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 5711101PF 6.5 5711102PF 7 5711103PF 7.5 5711104PF 8 5711105PF 8.5 5711106PF 9 5711107PF Downloads: Product Data Sheet Product Catalog24

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Secure Personal Protection: ENCORE Sensi-Touch PF surgical gloves are powder-free and feature a strong glove formulation, granting everyday protection you can depend on for general surgical procedures Reliable Comfort And Fit: These sterile surgical gloves have been designed using Ansell’s proprietary anatomic formers to offer comfort and dexterous hand movement Effortless Donning: Thanks to their polymer-coated internal finish, these dependable surgical gloves are both fast and easy to don Reliable Grip: These latex surgical gloves also feature a smooth external surface, with a micro-textured finish, for secure instrument handling Chemo-Tested: They have been tested for use with chemo-drugs, in accordance with ASTM D6978 requirements Key Features And Benefits: Strong Glove Formulation: Dependable everyday protection Anatomic Design: Secure and comfortable fit Polymer-Coated On The Inside: Fast and easy donning Recommended For: Brief, low-risk examination procedures Sterile procedures in the O.R. Use as an outer glove when double gloving Sterile procedures outside of the O.R. Primary Industries: Healthcare Product Details: Packaging: Size Code 5.5 7821PF 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 7822PF 6.5 7823PF 7 7824PF 7.5 7825PF 8 7826PF 8.5 7827PF 9 7828PF Downloads: Product Data Sheet Product Catalog24.05 MB (pdf)

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Superb Dexterity And Tactile Sensitivity: The latex surgical gloves’ optimal thickness, made possible because of its soft yet robust formulation, offers the wearer the dexterity and tactile sensitivity needed for safe and efficient performance Elevated Ergonomic Comfort: Together, the unique anatomic formers and soft latex formulation of these powder-free surgical gloves have resulted in certification for ergonomic comfort by United States Ergonomics Excellent Grip: ENCORE Latex Acclaim feature a smooth external surface with a micro-textured finish to enable a safe and secure grip of medical instruments especially when conditions are wet Enhanced Donning Aid: Ansell’s proprietary donning aid technology ensures effortless donning, be it the first don or during intraoperative changes Tested For Chemo Handling: These latex surgical gloves have been tested in accordance with ASTM D6978 and may be safely used to handle a range of chemo drugs Key Features And Benefits: Soft Yet Robust Formulation: Optimized comfort and tactile sensitivity Ergonomic Design: Reduced hand muscle effort during surgery Micro-Textured External Finish: Safe and secure grip of medical instruments Recommended For: Tested for use with chemotherapy drugs Extra comfort during long, sustained procedures Damp donning Use as an outer glove when double gloving Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 330100055 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 330100060 6.5 330100065 7 330100070 7.5 330100075 8 330100080 8.5 330100085 9 330100090 Downloads: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Chemical Recommendation Guides

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Surgical Gloves, Sterile, Powder Free PF With Glycerol The Encore HydraSoft powder-free latex surgical glove is designed to retain moisture and rehydrate your skin, despite continual glove wearing and frequent contact with astringent hand cleaners and disinfectants. Encore HydraSoft helps keep your skin moist and supple by fulfilling its natural barrier function.

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Heightened Dexterity: Being 20% thinner than Ansell’s standard powder-free latex gloves, ENCORE Latex Micro offers an exceptional level of tactile sensitivity and dexterity preferred for delicate procedures Elevated Ergonomic Comfort: Ansell’s unique anatomic glove formers deliver surgical gloves designed for enhanced comfort and movement to help reduce hand fatigue Double-Gloving Versatility: This micro glove’s brown color diminishes surgical glare while offering the wearer the option to use it as an inner glove when double gloving for easy breach detection Enhanced Donning Aid: A unique internal coating enables easy donning and doffing under dry or damp hand conditions, be it the first don or during intra-operative changes Key Features And Benefits: Micro Thin: Made 20% thinner for enhanced precision performance Brown Color: Reduces glare of bright surgical lights to prevent eye fatigue Smooth With Micro-Textured Finish: Unique surface offers secure grip Recommended For: All surgeries, especially delicate procedures in ophthalmology, micro, and cardiovascular Damp donning Enhanced tactile sensitivity and dexterity, especially for delicate procedures Prevention of eye fatigue Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 330104055 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 330104060 6.5 330104065 7 330104070 7.5 330104075 8 330104080 8.5 330104085 9 330104090 Downloads: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Chemical Recommendation Guides Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf)

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Optimal Thickness: On average, ENCORE Latex Ortho surgical gloves are 50% thicker than standard Ansell latex surgical gloves, providing outstanding hand protection for rigorous ortho procedures, especially from the use of power tools and where bone fragments are present Enhanced Grip: The heavy-textured external finish of these sterile ortho surgical gloves enhances grip performance, facilitating the secure handling of power tools in both dry and wet conditions Effortless Donning: ENCORE Latex Ortho gloves are powder-free, with a unique donning aid technology, featuring a polymer-lined inner coating, for speedy and easily dry and damp hand donning, whether it is the first don or during intra-operative changes Chemo-Tested For Safe Use: Tested for safe use with chemo-drugs in accordance with ASTM D6978 requirements Key Features And Benefits: 50% Thicker: Protection when power tools and bone fragments are present Heavy-Textured Finish: Superior grip in both dry and wet conditions Donning Aid Technology: Fast, easy donning with either dry or damp hands Recommended For: All surgeries, especially high risk procedures in orthopaedics, trauma, and cardiac Enhanced grip in wet environments Damp donning Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 6 330106060 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6.5 330106065 7 330106070 7.5 330106075 8 330106080 8.5 330106085 9 330106090 Downloads: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Chemical Recommendation Guides

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Enhanced Grip: The textured finish of these sterile latex gloves delivers exceptional grip on medical instruments under dry or damp conditions, making them ideal outer gloves when double gloving Heightened Tactile Sensitivity: The unique latex formulation and processes enable the thickness of these sterile gloves to be optimized for the wearer to experience the ideal balance of tactile sensitivity and hand protection Effortless Donning And Doffing: ENCORE Latex Textured surgical gloves are designed with a proprietary internal coating to facilitate easy dry and damp donning when first worn or during intra-operative changes Chemo-Tested: Tested to ASTM D6978, these textured latex gloves are safe to use with a wide range of chemotherapy drugs Key Features And Benefits: Textured Finish: Secure grip of instruments under dry or damp conditions Optimized Thickness: Ideal balance of tactile sensitivity and protection Proprietary Donning Technology: Effortless donning and doffing with either dry or damp hands Recommended For: Enhanced grip in wet environments Extra comfort during long, sustained procedures Damp donning Use as an outer glove when double gloving Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 5785000 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 5785001 6.5 5785002 7 5785003 7.5 5785004 8 5785005 8.5 5785006 9 5785007 Downloads: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf) Product Catalog24.05 MB (pdf)

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Contains glycerol and dimethicone as moisturizing agents to help retain moisture and rehydrate skin Low-friction outer-surface finish offers effortless donning and optimal comfort when double gloved Green color for easy identification of a glove breach The DERMASHIELD Technology internal coating together with the built-in moisturizer, facilitates dry and damp donning as well as intra-operative changes Key Features And Benefits: Helps keep skin moist and supple Effortless donning and optimal comfort when double gloved Easy identification of a glove breach Effortless dry and damp donning as well as intra-operative changes Recommended For: All surgeries, especially high-risk procedures in orthopedics, trauma, and cardiac Damp donning Easy identification of a glove breach Use as an under glove when double gloving Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 2018455 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 2018460 6.5 2018465 7 2018470 7.5 2018475 8 2018480 8.5 2018485 9 2018490 Downloads: Product Data Sheet Instructions for Use0.6 MB (pdf) Product Catalog24.05 MB (pdf)

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Free of latex and chemical accelerators to eliminate the risk of Type I latex allergies and minimize Type IV chemical allergies and skin sensitivities. SENSOPRENE MC formula for a thinner but robust glove for more comfort and durability Up to 30% thinner on average than standard Ansell neoprene surgical gloves for improved tactile sensitivity and dexterity Smooth with a micro-textured finish for safe gripping and handling of instruments Tested for use with different chemotherapy agents and a wide range of chemicals in hospitals Key Features And Benefits: Latex-free and total absence of chemical accelerators SENSOPRENE MC formula for a thinner but robust glove offering more comfort and durability Up to 30% thinner on average than standard Ansell neoprene surgical gloves Smooth with micro-textured finish for safe gripping and handling of instruments Tested for use with different chemotherapy agents and a wide range of chemicals Recommended Apps: All surgeries, especially delicate ophthalmological, microsurgical, and cardiovascular procedures Protection against Type I latex allergy and minimization of Type IV chemical allergies in healthcare professionals or patients Tested for use with chemotherapy drugs Use as outer glove in case of double gloving Main Industrial Sectors: Health care Integrated Technology: Product Details: Packaging: Size Coded 5.5 20277255 50 pairs per box; 4 boxes per case; 200 pairs per case 6 20277260 6.5 20277265 7 20277270 7.5 20277275 8 20277280 8.5 20277285 9 20277290 Download: Product Sheet Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf)

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Superior Comfort And Protection: Ansell’s proprietary soft yet strong formulation delivers heightened comfort and hand protection when double gloving Easy Breach Detection: Green in color, these sterile gloves enable fast and easy breach detection when worn with a cream or white outer glove Optimal Allergy Protection: Being non-latex, these polyisoprene surgical gloves eliminate the risk of developing a latex allergy while their skin-friendly formulation helps minimize sensitization to developing a Type IV chemical allergy as chemical accelerators known to cause skin allergies have been eliminated Effortless Donning And Doffing: A unique internal coating enables easy donning and doffing under dry or damp hand conditions Key Features And Benefits: Micro Thin: Optimal comfort, fit and feel when double gloving Green Color: Quick and easy breach detection Skin-Friendly Formulation: Not known to cause allergic contact dermatitis Recommended Apps: All surgeries, especially high risk procedures in orthopaedics, trauma, and cardiac Easy identification of a glove breach Protection from chemical accelerators such as thiurams, carbamates and mercaptos known to cause chemical Type IV allergies Having passed the Mouse Embryo Assay (MEA) test, may be used for In Vitro Fertilization (IVF) procedures Primary Industries: Healthcare Featured Technologies: . Product Details: Packaging: Size Code 5.5 20687255 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 20687260 6.5 20687265 7 20687270 7.5 20687275 8 20687280 8.5 20687285 9 20687290 Download: Product Data Sheet Declaration Of Conformity Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf) Instructions for Use0.6 MB (pdf) Product catalog24.05 MB (pdf)

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Elevated Tactile Sensitivity And Dexterity: The combination of Ansell’s unique soft, yet strong, polyisoprene formulation and process helps make GAMMEX Non-Latex PI Micro surgical gloves 15% thinner, delivering exceptional surgical finesse and hand protection Skin Friendly: These non-latex surgical gloves eliminate any risk of developing a Type I latex allergy, while their ground-breaking non-sensitizing polyisoprene (PI) formulation eliminates the use of chemical accelerators known to cause allergic contact dermatitis Excellent Grip Efficiency: The unique micro-textured external finish offers a safe grip when handling surgical instruments under both dry and damp conditions Chemo Tested: Having been tested per ASTM D6978, these sterile surgical gloves may be safely used with a range of chemotherapy drugs Key Features And Benefits: Micro Thin: Made 15% thinner for superb tactile sensitivity and dexterity Non-Sensitizing Formulation: No known risks of allergic contact dermatitis Smooth With Micro-Textured finish: Secure grip of surgical instruments Recommended For: All surgeries, especially delicate procedures in ophthalmology, micro, and cardiovascular Enhanced tactile sensitivity and dexterity, especially for delicate procedures Protection from chemical accelerators such as thiurams, carbamates and mercapto's known to cause chemical Type IV allergies Having passed the Mouse Embryo Assay (MEA) test may be used for In Vitro Fertilization (IVF) procedures Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 20685955 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 20685960 6.5 20685965 7 20685970 7.5 20685975 8 20685980 8.5 20685985 9 20685990 Download: Product Data Sheet Declaration Of Conformity Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf) Product Catalog24.05 MB (pdf)

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Reliable Allergy Protection: Made from synthetic polymers, using this sterile polyisoprene (PI) gloves eliminates Type I latex allergy risks while ZMBT, DPG, and CPC* are not used to protect wearers from these known allergens  Superior Comfort And Dexterity: Their soft yet strong formulation ensures wearers benefit from exceptional fit and feel Excellent Grip And Sensitivity: A smooth surface with a micro-textured finish offers the wearer secure handling and instrument grip during the most rigorous procedures Effortless Donning And Doffing: Their unique internal coating facilitates both dry and damp hand donning, either when first donned or during intra-operative changes Chemo Tested: Tested to ASTM D6978, these GAMMEX gloves are safe to use with a wide range of chemotherapy drugs Key Features And Benefits: Low Allergy Profile: Reduces risks to known allergens Soft Yet Strong Formulation: Exceptional comfort, dexterity, and hand protection Smooth With Micro-Textured Finish: Secure grip and instrument handling Recommended For: All surgeries, especially high-risk procedures in orthopedics, trauma, and cardiac Tested for use with chemotherapy drugs Primary Industries: Healthcare Product Details: Packaging: Size Code 5.5 20685255 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 20685260 6.5 20685265 7 20685270 7.5 20685275 8 20685280 8.5 20685285 9 20685290 Download: Product Data Sheet Declaration of Conformity – Regulation (EU) MDR 2017/7450.07 MB (pdf) Product Catalog24.05 MB (pdf)

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Optimal Allergy Protection: Being non-latex, these polyisoprene surgical gloves eliminate the risk of a latex allergy while minimizing sensitization to a Type IV chemical allergy as chemical accelerators known to cause skin allergies have been eliminated from its skin-friendly formulation Superior Comfort And Dexterity: Ansell’s proprietary soft yet strong formulation delivers exceptional fit and feel Excellent Grip And Sensitivity: The smooth surface of these surgical gloves has a micro-textured finish to ensure confident handling and instrument grip during the most rigorous procedures Effortless Donning And Doffing: A unique internal coating aids dry and damp hand donning, either when first donned or during intra-operative changes Chemo-Tested: Tested to ASTM D6978, these GAMMEX sterile gloves are safe to use with a wide range of chemotherapy drugs Key Features And Benefits: Skin-Friendly Formulation: Not known to cause allergic contact dermatitis Soft, Yet Strong: Improved wearer comfort, dexterity, and hand protection Smooth With Micro-Textured Finish: Excellent instrument handling and grip Recommended For: All surgeries, especially high-risk procedures in orthopedics, trauma, and cardiac Extra comfort during long, sustained procedures Protection from chemical accelerators such as thiurams, carbamates and mercapto's known to cause chemical Type IV allergies Having passed the Mouse Embryo Assay (MEA) test may be used for In Vitro Fertilization (IVF) procedures Primary Industries: Healthcare Featured Technologies: Product Details:   Packaging: Size Code 5.5 20685755 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 20685760 6.5 20685765 7 20685770 7.5 20685775 8 20685780 8.5 20685785 9 20685790 Download: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf) Product Catalog24.05 MB (pdf)

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Advanced Allergy Protection: GAMMEX Non-Latex neoprene surgical gloves are synthetic and eliminate risks of Type I latex allergy. These sterile gloves are made 100% free of chemical accelerators and minimize any risk of sensitization to allergens leading to allergic contact dermatitis. Proven Durability: Strong neoprene glove film deliver the added hand protection needed for the most rigorous procedures Confident Grip: These sterile gloves feature an external micro-textured finish for firmer, more confident instrument handling  Effortless Donning: Ansell’s donning aid technology includes an internal polymer coating that facilitate easy dry or damp donning  Chemo Tested: In addition, these long-cuff gloves are tested against ASTM D6978 and recommended for the safe handling of chemotherapy drugs Key Features And Benefits: Chemical Accelerator-Free Formulation: Advanced protection from allergies Neoprene Film Strength: Proven to withstand the most rigorous procedures Smooth With Micro-Textured Finish: Confident instrument handling and grip Recommended For: Damp donning Protection from latex Type I allergy and minimize chemical Type IV allergies in HCWs or patients Tested for use with chemotherapy drugs Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 8511 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 8512 6.5 8513 7 8514 7.5 8515 8 8516 8.5 8517 9 8518 Download: Product Data Sheet Product Catalog24.05 MB (pdf)

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Elevated Comfort: Thanks to their ridged back-of-hand and finger relief zones, GAMMEX PI Ergo-Fit sterile surgical gloves feel more spacious and require 20% less muscle effort, resulting in an optimized range of motion and barehand-like comfort Reduced Allergy Risks: These polyisoprene non-latex disposable gloves are free from diphenyl guanidine (DPG) and cetyl peridium chloride (CPC), eliminating the risk of latex Type I allergies and minimizing chemical Type IV allergies and sensitivities Facilitated Donning: GAMMEX PI Ergo-Fit disposable surgical gloves features DERMASHIELD Technology, an internal coating that allows for fast and easy donning in dry and damp conditions Key Features And Benefits: Stress Area Relief Zones: Optimized range of motion and better comfort Non-Latex, DPG- And CPC-Free Design: Fewer Type I and Type IV allergies DERMASHIELD Technology: Agile donning in dry or damp conditions Recommended For: All surgeries, especially for long, sustained procedures Use as an outer glove when double gloving Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 340064055 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 340064060 6.5 340064065 7 340064070 7.5 340064075 8 340064080 8.5 340064085 9 340064090 Download: Product Data Sheet Instructions for Use0.6 MB (pdf) Product Catalog24.05 MB (pdf)

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Enhanced Comfort And Durability: Made with Ansell’s proprietary synthetic blend technology, these non-latex surgical gloves combine the latex-like comfort of polyisoprene (PI) with the durability of neoprene so wearers experience the best of both worldsReduced allergy risks: Being a non-latex surgical glove, GAMMEX PI Hybrid eliminates the risk of a latex allergy while a range of allergens* known to cause allergic contact dermatitis are eliminated Enhanced Comfort And Durability: Made with Ansell’s proprietary synthetic blend technology, these non-latex surgical gloves combine the latex-like comfort of polyisoprene (PI) with the durability of neoprene so wearers experience the best of both worldsReduced allergy risks: Being a non-latex surgical glove, GAMMEX PI Hybrid eliminates the risk of a latex allergy while a range of allergens known to cause allergic contact dermatitis are eliminated Certified Ergonomic Performance: This PI surgical glove is certified by United States Ergonomics with a reported 32.3% reduction of hand muscle effortDouble gloving advantage: This semi-transparent glove is an excellent outer glove for double gloving with a colored under glove to offer easy breach detectionChemo-Tested: ASTM D6978 tested and may be used with a range of chemo drugs This PI surgical glove is certified by United States Ergonomics with a reported 32.3% reduction of hand muscle effortDouble Gloving Advantage: This semi-transparent glove is an excellent outer glove for double gloving with a colored under glove to offer easy breach detectionChemo-tested: ASTM D6978 tested and may be used with a range of chemo drugs Key Features And Benefits: Hybrid Technology: The comfort of polyisoprene and durability of neoprene Low-Allergenic Formulation: Reduced risks to a range of allergens* Semi-Transparent Design: Fast and easy breach detection when double gloving Recommended For: Easy identification of a glove breach Protection from Type I latex allergy in HCW's or patients Use as an outer glove when double gloving Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 340063055 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 340063060 6.5 340063065 7 340063070 7.5 340063075 8 340063080 8.5 340063085 9 340063090 Download: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Chemical Recommendation Guides

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Enhanced Grip: These synthetic surgical gloves’ textured finish enhances instrument grip, for secure handling in wet environments, especially during high-risk procedures Easy Double Gloving: Best used as an outer glove when double gloving, Ansell’s proprietary donning aid technology includes an inner polymer coating to facilitate donning and doffing during intra-operative changes Optimized Allergenic Prevention: These sterile polyisoprene gloves eliminate the risk of developing a latex allergy and help prevent sensitization to allergic contact dermatitis, as they are not made with chemical accelerators known to be allergens Chemo-Tested: GAMMEX Non-Latex PI Textured gloves are tested for handling with a range of cytotoxic drugs per ASTM D6978 Key Features And Benefits: Textured External Finish: Firm instrument grip in wet or dry conditions Donning Aid Technology: Fast and easy donning and doffing Skin-Friendly, Non-Sensitizing Formulation: Low dermatitis potential Recommended For: All surgeries, especially high-risk procedures in orthopedics, trauma, and cardiac Enhanced grip in wet environments Protection from chemical accelerators such as thiurams, carbamates and mercapto's known to cause chemical Type IV allergies Use as an outer glove when double gloving Having passed the Mouse Embryo Assay (MEA) test may be used for In Vitro Fertilization (IVF) procedures Primary Industries: Healthcare Featured Technologies: Product Details: Packaging: Size Code 5.5 20688255 50 pairs per box; 4 boxes per carton/case; 200 pairs per carton/case 6 20688260 6.5 20688265 7 20688270 7.5 20688275 8 20688280 8.5 20688285 9 20688290 Download: Product Data Sheet Declaration Of Conformity UK Declaration Of Conformity Declaration of Conformity – Regulation (EU) MDR 2017/7450.08 MB (pdf) Product catalog24.05 MB (pdf)

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Protective fluid-resistant 3-layer SMS fabric 21 X 30 X 49 inch Ultrasonically sealed seams Application Protective Procedure Gown Back Style Full Back Color Blue Cuff Style Knit Cuff Fastening Type Hook and Loop Neck / Waist Tie Material SMS Protection Level Not Rated Sleeve Style Long Sleeve Sterility NonSterile Type Over-the-Head / Isolation

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Tape-tab neck closure Tie waist Lightweight 3-layer SMS fabric Hot melt glued seams Specifications    Brand Halyard Basics Manufacturer O&M Halyard Inc Country of Origin China Application Protective Procedure Gown Back Style Full Back Color Yellow Cuff Style Elastic Wrist Fastening Type Tape Tab Neck / Waist Tie Material SMS Protection Level AAMI Level 2 Sleeve Style Long Sleeve Sterility NonSterile Usage Disposable

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Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes.Internal Control. Metals Free. Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Innovative highly sensitive red ink was developed to turn to yellow when the indicator is exposed to Plasma or Vaporized Hydrogen Peroxide. Endpoint condition: 50 ºC, 6 minutes, 2.3 mg/l H2O2. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Chemdye® CD42 Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the yellow reference color when the sterilization parameters are reached. For reference color, please refer to Result Reference Guide. More Info About This Product: Color Chart

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CD40 / Multi-variable Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes. Control of plasma or vaporized H2O2 sterilization processes. Conditions: 6 minutes, 50 °C, 2,3 mg/l H2O2. Characteristics: Type 4 Chemical Indicator (according to ISO 11140-1). Strips printed with indicator ink. Size: 105 x 18 mm (approximate). Initial color: Purple. Final color: Green. 100 % Toxic Heavy Metals free. Instructions For Use: Place a Chemdye® CD40 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the green or lighter reference color when the sterilization parameters are reached. Specifications: Process: Hydrogen peroxide Initial Color: Purple Final Color: Green Indicator Type: Type 4 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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IT26-C / Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance. Specifications: Process: Steam Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: User Manual

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IT26-C Extender/ Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. 4After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. NOTE: In some extended or wet steam cycles, the dark bar can display discoloration in some zones of the reading window, imposing a difficulty for result´s interpretation (see Result Reference Guide for reference). Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance.

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2 level chemical integrator for Ethylene Oxide sterilization processes. One-side laminated strips. Metals free. Integron® IT12 Chemical Integrators (Type 5 according to ISO 11140-1:2014 standard) are single-use two level chemical indicators that consist of paper strips laminated on the back side and printed with indicator ink. They have been designed for monitoring Ethylene Oxide (EO) sterilization processes. The integration level contains a purple/brown ink which was developed to turn to green when a theoretical spore population reaches its kill time, thus indicating that the SAFE condition has been met. Level 1 – Red: Exposure level. Indicator ink turns yellow to indicate exposition to the process, but does not ensure that the variables required to achieve the integration condition have been achieved (UNSAFE condition). Level 2 – Purple / brown: Integration level. Indicator ink turns green to indicate that the integration condition indicated in the quality certificate has been achieved. This condition consists of the kill time of a theoretical 106 Bacillus atrophaeus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer), and is called SAFE condition. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Integron® IT12 Chemical Integrator along with the material to be sterilized in a suitable package according to the recommended sterilization techniques. Place the indicators in those areas of most difficult access to the sterilizing agent. Perform the sterilization cycle. After the sterilization process has finished and evacuation/ventilation process is over, you may:               A. Remove the integrator indicator taking the necessary precaution to avoid                          contact with the remaining sterilizing agent.              B. Ventilate the load together with the integrator indicator and then perform                        the reading. Analyze the results. If the SAFE integration condition has been reached, the        sterilization process has been effective. Specifications: Process: Ethylene Oxide Initial Color: Level 1 Red, Level 2 purple-brown Final Color: Level 1 Yellow, level 2 Green Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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IT26-1YS / Unique point chemical integrator for Steam sterilization processes between 121° C and 134° C. Control of Steam sterilization processes between 121 ºC and 135 ºC. Characteristics: Type 5 Integrator Indicator (according to ISO 11140-1). One-side-laminated strips printed with indicator ink. Size: 70 mm x 23 mm. Initial Color: Yellow. Final Color: Black. 100 % Toxic Heavy Metal free. Instructions For Use: Place a chemical integrator Integron® IT26-1YS within each package, bag or tray that will be sterilized by Steam. In rigid containers place an IT26-1YS in every corner, or at least two diagonally opposite corners, to ensure that steam has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Steam, the ink must turn to the black reference color when the integration conditions are reached. Specifications: Process: Steam Initial Color: Yellow Final Color: Black Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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CDWAH-U / Stainless steel re-usable holder of great resistance and durability. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines. Base: 32,7 mm wide, 72,5 mm long. Designed to hold Chemdye® CDWA cleaning indicators and perform routine control of cleaning processes in ultrasonic washers. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines, without representing a challenge to the washing process. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO/TS 15883-5

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Holder for cleaning and thermodisinfection Indicators. Stainless Steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72 mm long, pin at the back side. ISO/TS 15883-5. Designed to hold Chemdye® CDWA and Integron® IT27W indicators in order to perform routine control of cleaning and thermal disinfection processes in automatic machines. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. Basket: 32 mm wide, 37 mm long, 0.5 mm thick. The holder is designed to mimic the cleaning challenges posed by a large process load during the washing cycle and can be fixed on the tray, which allows reproducible location of the cleaning indicator in the washer-disinfector. When CDWA4 is placed within the holder, half of the test soil is obscured, thus simulating the joint of a surgical instrument, with water stream hitting it indirectly. The other half of the test soil is covered by a mesh, thus posing a difficulty for water stream to reach it, mimicking shadowed or occluded surfaces. The new design of CDWAH optimizes the control of the washer disinfectors ability to force water and detergent into and onto the test soil. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO 15883

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Instructions For Use: Before The Test: Place the holder around the neck of the capsule. Press the holder down so that the groove of the holder fits securely around the neck of the vial. Insert the L shaped end on either side of the holder into the holes of the Ultrasonic device’s basket to hold the vial in position. The holder can be attached to a wire basket or perforated basket. Vials should be placed in the correct location within a tray / basket according to Ultrasonic Cleaning Indicator´s IFU based on the size of the tank. After the test is complete After the ultrasonic cycle remove the vial holding it with three fingers of one hand and the index finger and thumb of the other hand on the holder and lid of capsule. Place the index finger on the end of the holder, then place the thumb on the lid of the capsule for support, push the holder back off the neck of the capsule and remove the holder with both fingers.

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CDWA4 / Cleaning Indicator for cleaning performance tests. Challenge level: very high. Detects all the factors that affect the result of a washing process. Initial Color: Fuchsia. Result: removal of the fuchsia organic substance. Designed for routine control of cleaning processes and for monitoring automatic washing machines effectiveness as well as monitoring ultrasonic washing machines which operate at frequencies equal to or greater than 35 kHz, and temperatures between 30 ºC and 70 ºC. Characteristics: Challenge Level: Very high. Allows detection of all factors affecting the outcome of cleaning process. Initial Color: Fuchsia. Size: 70 mm x 30 mm (approximate). Synthetic temperature-stable support. Result: Elimination of fuchsia organic substance. To interpret results visually, use the results reference guide on product´s instructions for use. Optionally, the readout of the cleaning indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Choose the Chemdye® Splat CDWA indicator according to the desired difficulty. Place the indicator on the Chemdye® Splat CDWAH or Chemdye® Splat CDWAH-U holder. Place the system on the tray along with the material. Once the cleaning cycle is over, remove the indicator. Analyze Chemdye® Splat CDWA indicators using the reference table and record results. If unfavorable results are obtained, perform the appropriate corrective actions and repeat the washing process. Specifications: Process: Cleaning and thermodisinfection Initial Color: Fuchsia Regulations: ISO 13485, ISO/TS 15883-5

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Super Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 1 hour. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 1 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Note: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132 ºC and at 135 ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT222 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT222 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 1 hour at (60 ± 2) °C for super rapid readout. Specifications: Process: Steam Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 1 h Regulations: IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3

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Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 37 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process. 7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Instructions For Use: Identify the Terragene® Bionova® BT110 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT110 SCBI from the sterilized package. Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Ethylene Oxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 4 hours at (37 ± 2) °C for rapid readout. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 4 hours of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. If chamber relative humidity is unknown or < 35 %, continue to incubate the Biological Indicator for a pH color change result, since low relative humidity may increase the fluorescent readout time beyond 4 hours. Specifications: Process: Ethylene Oxide Microorganism: Bacillus atrophaeus (ATCC 9372) Population: 10^6 Spores/carrier Read-Out Time: 4 h Regulations: IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2 Length: 40 mm

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Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes. Indications For Use: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators have been designed for quick and easy monitoring of Plasma or vaporized hydrogen Peroxide sterilization cycles. Device Description: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearotermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT98 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. Precautions: Warning: Do not use Terragene® Bionova® BT98 SCBI to control EO, Dry Heat, Formaldehyde or other sterilization processes different from specified. Do not reuse SCBI. Warning:  Place one or more SCBI in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized. Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a SCBI in each of those locations. Warning:  Do not reuse the sterilizer until the SCBI test result is negative. Instructions For Use: Identify the Terragene® Bionova® BT98 SCBI by writing the sterilizer number (incase of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. Caution Wear safety glasses and gloves when removing the Terragene® Bionova® BT98 SCBI from the sterilized package. ( Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Hydrogen Peroxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® auto-reader incubators for a maximum of 5 minutes at (60 ± 2) °C for hyper rapid readout. (Holding time between sterilization and incubation should not exceed a 1-hour period.) Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; the capability of the medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 5 minutes of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. Record positive results and discard the SCBIs immediately, as it is indicated below. Hyper Rapid Readout: 5 minutes The hyper rapid readout must be carried out in the appropriate Terragene® Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 5 minutes of incubation. Fluorescence readout is an indirect measure of the viability of Geobacillus stearothermophilus spores after the sterilization process (positive results). Furthermore, a failure in the sterilization process can also become evident by culture medium color-change. Due to the high sensitivity of the fluorescence results at 5 minutes, conventional incubation for color change of Terragene® Bionova® SCBI BT98 is not an advantage. Visual Confirmation: 5 days: Optionally, you can perform a visual color-change confirmation after a 5-day incubation. If the sterilization process has not been successful, culture medium will turn to yellow during incubation at (60 ± 2) ºC, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid. ( If 5-day readout is performed, a humidified environment will be required to prevent medium from drying out.) Readout Time: 7 days A 7-day readout is optional and may be routinely performed. This is an initial validation of the 5-minute readout. Fluorescence results are compared to the 7-day visual readouts. Monitoring Frequency: Follow facility policies and procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As the best practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate biological indicator. Storage: Store in a dark place at temperature between 10-30 ºC and 30-80 % relative humidity. Do not freeze. Do not store biological indicators near sterilizing agents or other chemical products. Shelf Life: Biological Indicators have an expiration date of 2 years from the date of manufacture when stored at recommended conditions. Do not use indicators after their expiration date. Chemical Process Indicator on SCBI label have an expiration date of 2 years when used as part of SCBI. Endpoint Stability Reaction: Chemical Process Indicator endpoint shall remain unchanged for a period of 6 months when stored at previously indicated conditions. Disposal: Discard biological indicators after use according to your country’s healthcare and safety regulations. The positive biological indicators can be autoclaved in a gravity air displacement steam sterilizer at 121 ºC for 5 minutes, 132 ºC for 15 minutes or 134 ºC for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 minutes. Specifications: Population: 10^6 Spores/carrier Read-Out Time: 5 min Regulations: IRAM 37102-1:1999, ISO 11138-1:2017, ISO 13485:2016 / NS-EN ISO 13485:2016

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Ultra Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 20 minutes. An optional visual pH color change confirmation could be made after 48 hours of incubation. If the sterilization process has not been successful, the culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If the sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 20 minute-reading. Fluorescence results may be compared to the 7-day visual reading. Note: If 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132ºC and at 135ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT224 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT224 SCBI from the sterilized package. (Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) 5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. ( This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process.) 6. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. 7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 20 minutes at (60 ± 2) °C for ultra rapid readout. Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; capability of medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means a failure in the sterilization process. If no fluorescence is detected at 20-minute incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for a visual color change.

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