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GGL30NITM9 Inner Box Image
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BioClean™ Nitrile Sterile Isolator Mitten GGL30NITM9

Validated Sterile Nitrile RABS / Isolator Mitten

Key Features and Benefits

  • ASTM D6978-05-tested: Certified for the safe handling of cytotoxic drugs
  • 100% water leak-tested: Isolator mittens with reduced contamination risks
  • ISO 4 cleanroom-processed: Excellent cleanliness levels
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Standards and certifications

Standards and certifications

ASTM D6978
CE 0598
EN 420:2003 + A1:2009
Category III
EC 1935/2004
ISO 11137-1:2006
EN 421:2010
EN ISO 374-1:2016 AJKNOT
EN ISO 374-5:2016
EN 388:2016 4101X
EN 455 Part 2
Description

Description

  • Specialized protection: Designed for use in injectable manufacturing and pharmaceutical production areas, the BioClean™ Nitrile Sterile Isolator Mitten GGL30NITM9 is tested against ASTM D6978-05 permeation standard to ensure safe chemotherapy drug handling and resistance to common chemicals
  • Reduced contamination risk: These autoclavable cleanroom mittens are 100% water leak tested, minimizing the risk of contamination and ensuring effective arm and hand protection
  • Optimized cleanliness: Made to fit 10” (254 mm) ports, these mittens are ISO 4 cleanroom-laundered and -packaged, ensuring low particle levels
  • Improved fit: BioClean™ The BioClean™ Nitrile Sterile Isolator Mitten GGL30NITM9 is specially designed to reduce hand fatigue
Primary industries

Primary industries

  • Life Sciences
  • Healthcare
  • Electronics
Featured technologies

Featured technologies

NRL Free
Product details

Product details

  • AVAILABLE SIZES 9.75
  • 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) 100% leak tested
  • GLOVE LENGTH (MM/INCHES) 840/33
  • MATERIAL Nitrile
  • PORT SIZES 10"
  • 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) 0.50/20
  • FINGER THICKNESS (MM/MIL) 0.60/24
  • CUFF THICKNESS (MM/MIL) 0.50/20
Packaging

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)
Size Code Packaging
9.75 GGL30NITM9 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)
Downloads

Downloads

Product Data Sheet
Declaration Of Conformity
UK Declaration Of Conformity
Food Declaration of Product Conformity
GMP Declaration 0.29 MB (pdf)
IFU 2.91 MB (pdf)

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