CE marked in accordance with EU Directive on Medical Devices 93/42 / EEC, Annex V.3&Vii, Class 1 rule 1. Type IIR approved in accordance with EN 14683:2019. We guarantee Bacteria Filter Effect (BFE) of ≥ 98% and splash resistance. Biocompatibility tested. Only available in increments of 50 (minimum order quantity 50 pieces). Delivered in a carton box of 10 x 8 x 19 cm. Non-woven polypropylene.