Product Description Nitrile Examination Gloves, Non Sterile, Powdered or Non-Powdered Ambidextrous Key Specifications/Special Features : Medical Device: in compliance with European Medical Device Directive 93/42/EEC (CE Class l) EN 455 Parts 1, 2, 3 and 4 ASTM D6319 US FDA 510k ISO 9001 ISO 13485" Minimum Order Size and Packaging details : MOQ 1,000,000 pieces. 100 pieces per box. 10 Boxes per master carton