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