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).