BioClean Nitrile Sterile Isolator Mitten GGL30NITM9

Validated Sterile Nitrile RABS / Isolator Mitten

BioClean validated sterile RABS and Isolator Mittens are manufactured from nitrile with incredibly low levels of particles and excellent ESD properties. Designed for use in product contact areas, our GGL mittens are fully validated for sterility with an SAL (Sterility Assurance Level) of 10^-6 .

• Product color: white
• Cuff style: beaded
• External Glove Surface: smooth
• Freedom from holes (Inspection Level I): 100% leak tested
• Glove length (mm/inches): 800/32
• Material: nitrile
• 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): 0.45/17.72
• Finger Thickness (mm/mil): 0.55/21.65
• Fits 10-12"/254-304mm Port - GGL30NITM9

Industries

• Life Sciences

Categories / Standards / Certifications

• ASTM D6978
• CE 0598, EN 420:2003 + A1:2009; EN 420:2003 + A1:2009; Category III
• EN 421
• EN ISO 374-1, 2, 3
• EN 388 4101X
• EN 455 Part 2
• ISO 11137-1

Packaging

One piece per sealed inner PE bag; one inner bag per sealed second inner PE bag; one second inner bag per sealed outer PE bag; 20 outer bags per lined inner white Correx polyethylene box (20 pieces PDS