Certifications: Manufactured in a facility holding ISO 9001:2015 and (EU)2016/425 Module D certifications.
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 European Glove Standards EN 420:2003 +A1:2009, EN 374-1:2016, EN 374-5:2016 and EN 421:2010.
Physical properties comply with European Medical Glove Standard EN 455-2:2015.
Sterilized in accordance with ISO 11137-1:2006.
Suitable for contact with all foodstuffs. Regulation (EC)1935/2004 and (EC) 2023/2006.
Tested against permeation standard ASTM D6978-05 for cytotoxic drugs.

Packaging: Sterile version: One cuffed pair per plastic wallet; one wallet per EasyTear™ PE pouch; 10 pairs per sealed outer PE bag; 20 outer bags per carton liner; one carton liner per carton (200 pairs). Non sterile version: 100 pieces per sealed inner PE bag; one sealed inner PE bag per sealed outer PE bag; 10 outer PE bags per carton liner; one carton liner per carton (1000 pieces).