Certifications/Compliance: PPE Category III by EC Council Directive 89/686/EEC. Tested in accordance with the EN Norms EN420:2003, ISO 16604 procedure B:2004, EN1149-5:2003, EN421:2004, Meets or exceeds AQL 0.65 G1 Inspection for pinholes, ISO 9001 and ISO 13485, FDA CFR 21 part 820 Classification: PPE Category III. Accelerator Free: Yes. Color: Purple.