Sterile Nitrile RABS Isolator Gauntlet
Bioclean Nitrile Gauntlets
Sterile Nitrile RABS Isolator Gauntlet

Bioclean Sterile Nitrile RABS / Isolator Gloves

BioClean validated sterile RABS and Isolator Gloves are manufactured from nitrile with incredibly low levels of
particles and excellent ESD properties. Designed for use in product contact areas, our GGL series of gloves are fully validated for sterility with an SAL (Sterility Assurance Level) of 10-6 and are available in a range of port sizes.

Description

Specifications
COMPATIBILITY: ISO Class 4 & EU GMP Grade A
LENGTH: 840mm/33″
MATERIAL: Nitrile
PROTEIN LEVEL: Nitrile contains no natural latex proteins
SURFACE: Smooth
SHAPE: 5 Finger Ambidextrous Size 9.75
COLOUR: White
STERILIZATION: Gamma irradiation

Features
Tested against ASTM D6978-05 for handling chemo drugs
Ultra-clean surface ensures product protection
Four port sizes available:
GGL15NIT59 – 6 – 8″/152 – 203mm
GGL20NIT59 – 8 – 10″/203 – 254mm
GGL33NIT59 – 10 – 12″/254 – 305mm
GGL36NIT59 – 12 – 14″/305 – 356mm

Quality Standards
Manufactured in a facility holding ISO 9001:2015 and PPER 2016/425 Module D
Conforms to Category 3 – Complex Design Personal Protective Equipment PPE Regulation (EU)2016/425
Processed in an NEBB certified ISO Class 4 environment Complies with the requirements of Glove Standard EN420:2003
+A1:2009, EN374-1:2016, EN374-5:2016
Physical properties comply with European Medical Glove Standard EN455-2:2015
Tested against permeation standard ASTM D6978-05 for cytotoxic drugs
Suitable for contact with dry,alcoholic and acidic foodstuffs. Regulation (EC)1935/2004 and (EC) 2023/2006.
Sterilized in accordance with ISO 11137-1:2006
Mechanical protection EN388:2016
Complies with the requirements of European Glove Standard EN421
Protection against particulate radioactive contamination.

Sterilization
Method: Gamma irradiation
Minimum Dose: 25kGy
Sterility Assurance Level: 10 -6

Shelf Life & Storage
Three (3) years from date of manufacture. Store in a dry, cool place
(<40°C) away from direct sunlight and fluorescent light. Packing Triple bagged: 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).

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