Face Masks Type IIR We are offering high quality Medical Face Masks with ear loops Type IIR as per EN 14683 that have Bacterial Filtration Efficiency (BFE) > 98%. Our masks are packed in boxes of 50 pcs (each box contains properly labelled 5 bags of 10 pcs each) for easy distribution in either professional healthcare or retail market during virus pandemic. Our product is certified for conformity with European Norms and the Quality Management System for design and manufacturing is compliant with International Standard ISO 13485:2016.To get more news about sterile mask factory outlet, you can visit tnkme.com official website. The table below indicates the performance requirements defined by EN14683-2019. his product meets European Standard EN14683 for medical face masks Type IIR. The product is also covered by Declaration of Conformity with European Directives, Document No. Gemtier/CE-34-11.1 for product Class I, non-sterile with CE mark according to Annex VIII of Regulation (EU) 2017/745. In addition, the manufacturer’s Quality Management System is certified for compliance with EN ISO13485:2016 by TÜV Rheinland LGA Products GmbH, Germany endorsed by DAkkS Deutsche Akkreditierungsstelle, Certificate No. SX 60138648 005. *Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements.