TYPE II Disposable Medical Mask. Compliance with MDD Eu Medical devices directive 92/42/EEC, implementation of standard EN14683:2019 TYPE II, SGS inspection report, and FDA. 50 Masks per box: 2,000 masks per carton. Total 3 plies.2 layers of water-repellent non-woven fabric (outer layer) and melt-blown fabric. Mask size: 17.5*9.5cm. Bacterial filtration efficiency (BFE) of 3.0 um ge 98%. Regular stock. FDA Registration #3016713638