Product Description Nitrile Surgical Gloves, Non Sterile, Powdered or Non-Powdered Ambidextrous Key Specifications/Special Features : "Personal Protective Equipment of Complex Design Category III, in compliance with European Regulation (EU) 2016/425, type tested to EN 420:2003+A1:2009, EN ISO 374-1:2016 Type B, EN 374-2:2014, EN 16523-1:2015, EN 374-4:2013 & EN ISO 374-5:2016, CE Class IIa Sterile Medical Device, in compliance with 93/42/EEC, type tested to EN 455-1:2000, EN 455-2:2015, EN 455-3:2015, EN 455-4:2009;CE2797; ASTM D3577; US FDA 510k; ISO 9001; ISO 13485"