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BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NIT85

Validated 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 0493
EN 420:2003 + A1:2009
EN 420:2003 + A1:2009
Category III
ISO 11137-1:2006
EN 421:2010
EN ISO 374-1:2016 Type B KPT
EN ISO 374-5:2016
EN 455 Part 2

Description

  • Integrated system: The BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NIT85, consists of a nitrile sleeve attached to a size 8.0 hand-specific, PCP glove (BioClean™ BPZS) by a channel ring and O ring
  • Specialized protection: To ensure optimal protection for workers handling chemotherapy drugs, the GSG10NIT85 Glove system is tested against ASTM D6978-05
  • Reduced contamination risk: The BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NIT85 is 100% visually inspected, reducing the risk of contamination and affording effective arm as well as hand protection
  • Enhanced features: This white RABS/isolator sleeve/glove system fits 8” (203 mm) ports and is autoclave compatible (sleeve only)

Primary industries

  • Life Sciences
  • Healthcare
  • Electronics

Featured technologies

NRL Free

Product details

  • AVAILABLE SIZES 8.5
  • 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 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 8.5 glove (marked L) and channel ring/O-ring assembly packed in inner PE bag; One system – consisting of sleeve, size 8.5 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 corrugated carton.

Size Code Packaging
8.5 GSG10NIT85 One system – consisting of sleeve, size 8.5 glove (marked L) and channel ring/O-ring assembly packed in inner PE bag; One system – consisting of sleeve, size 8.5 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 corrugated carton. 

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