Description
The BioClean-C Sterile Chemotherapy Protective Sleeve Covers have been specially developed for protection against a range of chemotherapy drugs†† and to be compatible with ISO Class 4 cleanrooms. Constructed from lightweight low-linting CleanTough blue material, the sleeve covers feature elasticized arms for stability on the arm and has been tailored for quick and simple donning.
• Ultrasonically bonded seams with protective tape
• Elasticized for secure fit
• Lightweight low-linting CleanTough material
• Tested against permeation standard ASTM F739-12
• Silicone-free
Specifications:
• Material: BioClean-C CleanTough blue material & 100% polyester cuffs
• Color: Blue
• Construction: Ultrasonically bonded seams covered with protective tape
• Classification: PPE Cat 3 Type PB 6
• Characteristics: Low particulating
• Compatibility: ISO Class 4
• Sterilization: Gamma irradiation
• Method: Gamma irradiation
• Minimum Dose: 25kGy
• Sterility Assurance Level: 10-6
• Packaging: One pair per sealed inner PE bag; 15 inner bags per sealed outer PE bag; six outer bags per lined carton (90 pairs)
Quality Standards:
• Manufactured in a facility holding ISO 9001:2015 and (EU)2016/425 Module D certifications
• Conforms to Category 3 – Personal Protective Equipment Regulation (EU) 2016/425
• Tested against standard EN ISO 13034:2005 + A1:2009 protective clothing against liquid chemicals (Type PB 6)
• Tested against standard EN 14325 protective clothing against chemicals
• Tested against permeation standard ASTM F739-12
• Processed in an NEBB certified ISO Class 4 environment
• Tested against standards: EN 530, Abrasion resistance; EN 6530,
• Resistance to penetration by liquids; EN 13934-1, Tensile strength; EN 9073-4, Trapezoidal tear resistance; EN 863, Puncture resistance; and EN 13935-2, Seam strength.
• Sterilized in accordance with ISO 11137-1:2006
††Please see product validation pack for specific data on use of garments with cytotoxic drugs. Garments used for protection against such drugs must be selected specifically for the type of chemicals used.
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