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BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NIT80

Clean & Sterile Nitrile RABS / Isolator Sleeve / Glove System

Key Features and Benefits

  • ASTM D6978-05-tested: Certified for the safe handling of cytotoxic drugs
  • ISO 4 cleanroom-processed: Exceptional cleanliness levels
  • Sterility Assurance Level (SAL) of 10-6: Sterile hand protection product

Standards and certifications

ASTM D6978
CE Number
EN ISO 21420:2020
EN 421:2010
EN ISO 374-1:2016 Type B KPT
EN ISO 374-5:2016 2016
UKCA

Description

    Port size: 203mm/8”

  • Integrated system: GSG10NIT80 combines a nitrile sleeve with a size 8.0 hand-specific PCP glove (BioClean™ BPZS) using a channel and O-ring
  • Specialized protection: ASTM D6978-05 tested for safe handling of chemotherapy drugs
  • Reduced contamination risk: Undergoes 100% visual inspection to minimize contamination and ensure full hand and arm protection
  • Enhanced features: Autoclave compatible (sleeve only) at 121°C for 30 minutes (15 cycles according to internal testing results), resistant to vaporized hydrogen peroxide (VHP) and isopropyl alcohol (IPA)

 

For cleaning of isolators with disinfectants (Users should conduct evaluation at their discretion for compatibility or seek Ansell consultation).

 

Primary industries

  • Life Sciences
  • Healthcare
  • Electronics

Featured technologies

NRL Free

Product details

  • AVAILABLE SIZES 8.0
  • CLEANROOM CLASS Class 10/ISO 4 & EU GMP Grade A
  • 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 SIZES 203mm/8"
  • SHAPE Hand Specific
  • 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
  • CUFF THICKNESS (MM/MIL) 0.50/20

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 cardboard box.

More sustainable packaging: These gloves are packed in recyclable plastic packaging* and delivered in recycled cardboard shipper cases.

*Inner wrap, pouch, bag and liner are made from polyethylene (PE) based film. Always check your local recyclable status as these materials may not be considered suitable for recycling in your location.

Size Code Packaging
8 GSG10NIT80 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 cardboard box.