Aurelia® Robust™ Blue Nitrile (Non-Latex) Powder Free Examination Gloves are made from 100% Nitrile (Non-Latex), ambidextrous, blue color, fully microtextured and non-sterile. Aurelia gloves conform and are tested to the highest international standards.
Aurelia Gloves conforms and complies with: - The general safety and performance requirements of FDA Medical Device Regulation for Class 1 medical devices (21 CFR 880.6250) and complies with all general controls (section 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c(a)(1)(A)) - The standard specification requirements for ASTM D6319- Freedom From Holes, Physical Dimensions Test, Physical Requirement Test and Packaging - The standard specification requirements for ASTM D6978-05 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs - EEC regulations concerning the conformity of materials and products that are allowed to come into contact with food. In accordance with Regulation EEC 1935/2004, Regulation EC 10/2011 & Regulation (EC) No 2023/2006. The gloves are certified manufactured according to ISO 9001:2015 and ISO 13485:2016 Quality Management Systems