CE certified Complies with EN 14683 : 2019 Standard In accordance with the Medical Devices Directive 93/42/EEC and EU Regulation 2017/745. Bacterial filtration efficiency BFE > 98% 3-layer hypoallergenic non-woven material construction 17.3 x 9.5 cm (universal size) The mask has an integrated adjustable nose wire and soft comfortable ear loop Light, soft, and skin friendly Does not obstruct breathing Single use mask