Description
Ambidextrous, powder-free, and crafted from 100% natural latex rubber, these no-frill non-sterile examination gloves are rigorously tested to confirm to the highest international standards, and are powder-free & micro-textured for maximum grip, comfort and and dexterity.
Features:
- 5.5 mil Thickness
- Beaded cuff
- Micro Textured
- AQL 1.5
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
