BioClean Nitrile RABS/Isolator Sleeve/Glove System GSG10NITXLMA

Validated Sterile Nitrile RABS / Isolator Sleeve/Glove System

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

• Product color: white, green
• Cuff style: beaded
• External Glove Surface: textured fingers
• Freedom from holes (Inspection Level I): aql 0.65 performance level 3 (glove)
• Material: nitrile, neoprene (polychloroprene)
• Port size: 10-12"
• Shape: ambidextrous
• 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): 0.10/3.94
• Finger Thickness (mm/mil): 0.12/4.72

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 8.0-8.5 ambidextrous glove and channel ring/O-ring assembly packed in inner PE bag; One system – consisting of sleeve, size 8.0-8.5 ambidextrous glove and channel ring/O-ring assembly packed in inner PE bag; two inner bags (two systems) packed per outer PE bag; 10 outer bags (20 systems) per lined white Correx box. Instructions for Use - 14.01 MB (pdf)