Nitrile Gloves Production Standards are constantly updated to meet all international standards. FDA 510k for United State and South America, Registration with Med-Canada and for Europe to the latest MDR Regulation 2017/745. EN ISO 455-1,2,3 EN ISO 374-1,2,4,5 EU Type Examination CE2777 Certificate from SATRA Europe EU Manufacturer Declaration of Conformity to comply MDR Regulation 2017/745 ASTM D-6319 FDA 510k Premarket Permanent Registration ASTM D6978 Chemotherapy Rated Gloves Category UK MHRA Confirmation Registration
