Surgical face mask (F-Y1-A Type IIR)
Material composition
Filtering system is designed and layered by surface 25g non-woven, second layer 25g BFE99 filtration material, inner layer 25g non-woven.
Scope of application
It is used to cover the mouth, nose and jaw of the user, and provides a physical barrier to prevent the direct transmission of pathogenic microorganisms, body fluids, particles, etc.
The F-Y1-A is a surgical face mask.
UMDN code: 12-458
Classification: Class 1
Rule: According to Rule 1, Annex V111, Chapter III of (EU) MDR 2017/745
Conformity assessment route: ANNEX II + ANNEX III + Article 19 of (EU) MDR 2017/745
It is declared by the manufacturer that F-Y1-A meets the provision of the Medical Device Regulation (EU) MDR 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. The EU declaration conformity is used under the sole responsibility of the manufacturer.
F-Y1-A standard applied:
EN ISO 13485:2016, EN ISO 14971:2012, EN 14683:2019 +AC:2019, BS EN ISO 15223-1:2016, EN ISO 10933-1:2009/AC:2010, EN ISO 10993-5:2009, ISO 10993-10:2010, EN 1041:2008
