Aurelia® Bold® Black Nitrile Gloves - 5-mil (100ct)

Aurelia®disposableBold®nitrile medical examination gloves combine all the best benefits of anitrile glovein a proprietary formulation that takes strength, comfort and performance to an all new level. Thesesingle-use latex-free exam glovesare ultra thin for precise touch technology yet strong enough to pull on without ripping the cuff. Silky, stretchy and soft texture drapes the hands without constricting the palm and is easy to put on. Black color is ideal for EMT/EMS, law enforcement, ink/tattoo, piercing, spas, salons and labs. Micro-textured fingertips for reduced slippage. Gloves are FDA 510k registered and meet or exceed all current FDA regulations and ASTM Standards for medical use. Tested and approved for chemo andfentanyl resistanceper ASTM D6978-05 standards. Ambidextrous. Made in Malaysia. Black color. 5-mil thick.

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))

• ASTM D的标准规范要求6319- Freedom From Holes, Physical Dimensions Test, Physical Requirement Test and Packaging

• ASTM D的标准规范要求6978-05 - 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