Respirator Mask - EN 149 Class FFP2

(NIOSH N95)

ONE-CARE™ is offering high quality Respirator Masks with ear loops Class FFP2 as per EN 149 (US NIOSH N95 equivalent) that have Particle Filtration Efficiency ≥ 94% for Most Penetrating Particles Size (MPPS) of 0.3 micron. Our masks are packed in boxes of 50 pcs and each mask is individually pouched for easy distribution in either professional healthcare setting or consumer market during virus pandemic. Our FFP2 Respirator Masks are certified for conformity with European Norms and the Quality Management System for design and manufacturing is compliant with International Standard EN ISO13485:2016.

Effective protection of the respiratory system of medical personnel

 

CONFORMITY WITH EUROPEAN NORMS, MEDICAL DEVICE DIRECTIVES AND INTERNATIONAL STANDARDS ISO

The table below indicates the performance requirements for respirator and surgical masks defined by EN 149 and EN 14683. This product meets European Standard EN149 : 2001 for respirator masks class FFP2. The product is also CE 0194 marked and covered by CE Certificate, Document No. CN/XMN6395, and Declaration of Conformity with European Directive, Document No. PPE20161886. In addition, the manufacturer’s Quality Management System is certified for compliance with EN ISO13485 : 2016 by SGS, Certificate No. CN15/30182.

Respiratory Mask of Class FFP2 is suitable for filtering of the most penetrating particles of 0.3 microns size that can be found in the air.

  • 0.1 micron: Particle Filtration Efficiency standard (PFE).

  • 0.3 micron: Used to represent the most-penetrating particle size (MPPS), which is the most difficult size particle to capture.

  • 3.0 microns: Bacteria Filtration Efficiency standard (BFE) for masks per EN 14683

 

NOTE: Masks are only effective when fitted and worn correctly. For more information on fitting, how to correctly fit-test a mask, and how to pick the right mask, please follow the national guidance from government institutions like US Center of Disease Control www.cdc.gov or WHO - World Health Organization www.who.int

Can Respirators Protect You From Coronavirus?

Respirators can help protect you from coronaviruses. However, ONLY if they are worn properly. There has been a lot of controversy over the impact of respirator, however, it is generally accepted that masks can help prevent the spread of the virus (if fitted correctly).


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