Lazaro ID

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.

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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 irradiationFeatures 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 – 356mmQuality 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 -6Shelf 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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