Regulation 2016/425. Conforms to EN149: 2001 + A1 2009 FFP2 CE. BFE >=95%. 4-ply non-woven fabric outer and inner layers with melt down non-woven filter fabric. Disposable, tighter fitting mask reduces exposure to small biological particles. Non-sterile and non-porous. Elasticated ear loops for comfort. Nose bridge bar provides better fit. Important - 1 unit = 1 pack of 50 masks. Disclaimer: We make no assurances that this mask can prevent the transmission or infection of disease or viruses. Non-returnable.