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Ansell

BioClean™ Nitrile Sterile Isolator Mitten GGL30NITM9

The BioClean™ Nitrile Sterile Isolator Mitten GGL30NITM9 has ultra-low levels of particles. It offers fully validated for sterility.

Product numberGGL30NITM9

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

Description

  • Port size: 254mm/10”
  • Specialized protection: Autoclave compatible at 121°C for 30 minutes (15 cycles according to internal testing results), resistant to vaporized hydrogen peroxide (VHP) and isopropyl alcohol (IPA), making it ideal for injectable manufacturing and pharmaceutical production
  • Advanced defense: Tested to ASTM D6978-05 for safe chemotherapy drug handling and chemical resistance
  • Reduced contamination risk & enhance safety: These mittens are 100% water leak tested, minimizing risk of contamination
  • Optimized cleanliness: Washed & packed in an ISO Class 4 cleanroom, ensuring low particulate levels
  • Enhanced comfort: Designed to reduce hand fatigue and enable easy donning
  • For cleaning of isolators with other disinfectants or disinfection method, users should conduct evaluation at their discretion for compatibility or seek Ansell consultation.

Primary industries

  • Life Sciences
  • Healthcare
  • Electronics

Product details

  • AVAILABLE SIZES 9.75
  • CLEANROOM CLASS Class 10/ISO Class 4 & EU GMP Grade A/B and other sterile cleanrooms
  • 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 254mm/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
AVAILABLE SIZES
9.75
CLEANROOM CLASS
Class 10/ISO Class 4 & EU GMP Grade A/B and other sterile cleanrooms
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
254mm/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

  • 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 cardboard box (20 pieces).
  • 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.

Product identifiers

Product number
GGL30NITM9

Product documents

Ürün Veri Sayfası↗EU Declaration of Conformity↗Gida Ürün Uygunluğu Beyani↗Certificate↗PPWR - Declaration of Conformity 0,46 MB (pdf)↗GMP Declaration 0 MB ()↗IFU 2,91 MB (pdf)↗

Manufacturer source

Official English product page↗