BioClean Sterile Nitrile RABS/Isolator Sleeve/Glove System GSG

Validated Sterile Nitrile RABS / Isolator Sleeve/Glove System

Clean & sterile sleeve/glove system, Nitrile sleeve attached to a size 8.0 or 8.5 hand specific PCP glove(BioClean BPZS) by a channel ring and o'ring. Sold by the pair, individually packaged. 914/36 mm/inches (System Length - Sleeve & Glove).

• Product color: white
• Cuff style: beaded
• External Glove Surface: smooth
• Freedom from holes (Inspection Level I): aql 0.65 performance level 3 (glove)
• Material: nitrile, neoprene (polychloroprene)
• Port size: 10"/254MM
• Shape: hand specific
• Cleanroom Class: class 10/ISO 4 & Eu Gmp Grade A
• Sterile: yes
• Tested for use with chemotherapy drugs: yes, in accordance with ASTM D6978 (not listed in the US FDA 510K)
• Palm Thickness (mm/mil): 0.15/5.91
• Finger Thickness (mm/mil): 0.18/7.09

Industries

• Life Sciences

Categories / Standards / Certifications

• ASTM D6978
• EN 420:2003 + A1:2009; EN 420:2003 + A1:2009; Category III
• EN 421
• EN ISO 374 - 1, 2, 3
• EN 455 Part 2
• ISO 11137-1

Packaging

One system – consisting of sleeve, size 8.0 glove (marked L) and channel ring/O-ring assembly packed in inner PE bag; One system – consisting of sleeve, size 8.0 glove (marked R) and channel ring/O-ring assembly packed in inner PE bag; two inner bags (two systems – one L & one R) packed per outer PE bag; 10 outer bags (20 systems) per lined white Correx box. GSG10NIT80 Product Datasheet - 0.13 MB (pdf)GSG10NIT85 Product Datasheet - 0.13 MB (pdf)Instructions for Use - 14.01 MB (pdf)