The BREATHE filtering half mask is manufactured for COVID-19 protection only. As requested by the World Health Organization recommendations, for this specific use, the nominal protection factor given by this filtering half mask is the same than the FFP2 nominal protection factor defined in EN149:2001+A1:2009. The nominal protection factor is referred only to performance against solid and water-based aerodispersed aerosols. This filtering half mask is not a filtering half mask for general use and shall not be used for purposes other than protection against COVID-19. BREATHE is in compliance with EU Regulation n. 2016/425 and the PPE-R/02.075 version 2 and it is certified by MTIC INTERCERT S.r.l notified body n. 0068 - Via Moscova, 11 - 20017 Rho (MI) Italy - The production is under control by the same Notified Body.The EU Declaration of conformity can be viewed on the website www.rcabignami.com/Breathe - Rca Bignami has certified its quality management system according to the ISO 9001: 2015 regulations.