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BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NITXLMA

Validated Sterile Nitrile RABS / Isolator Sleeve/Glove System

Key Features and Benefits

  • ASTM D6978-05-tested: Certified for the safe handling of chemotherapy drugs
  • ISO 4 cleanroom-processed: Excellent 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
Category III
ISO 11137-1:2006
EN 421:2010
EN ISO 374-1:2016
EN ISO 374-5:2016
EN 455 Part 2

Description

  • Integrated system: The BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NITXLMA comprises a nitrile sleeve attached to an L size, ambidextrous PCP glove (BioClean™ S-BFAP), by a channel ring and O ring
  • Specialized protection: The GSG10NITXLMA Glove System is tested against ASTM D6978-05 to optimize protection for workers handling chemotherapy drugs
  • Reduced risk: In addition, the BioClean™ Nitrile RABS/Isolator Sleeve/Glove System GSG10NITXLMAX is 100% visually inspected, lowering the risk of contamination and ensuring effective arm as well as hand protection
  • Enhanced features: The BioClean™ Isolator Sleeve Glove System GSG10NITXLMA is autoclave compatible (sleeve only), fits port size 8”/203 mm and features an extra length of 39”/995 mm that allows greater flexibility and comfort

Primary industries

  • Life Sciences
  • Healthcare
  • Electronics

Featured technologies

NRL Free

Product details

  • AVAILABLE SIZES L
  • CLEANROOM CLASS Class 10/ISO 4 & EU GMP Grade A
  • 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 SIZES 8"
  • SHAPE Ambidextrous
  • 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
  • CUFF THICKNESS (MM/MIL) 0.50/20

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 corrugated carton.

Size Code Packaging
L GSG10NITXLMA 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 corrugated carton.