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FFP3 Valved/Unvalved Mask

UK-tested and CE certified face mask offering the highest FFP3 grade protection.


EN-149 is one of the European Standard for masks while N95 masks are certified by the US National Institute for Occupational Safety and Health (NIOSH). Both types of masks are designed to reduce wearer's respiratory exposure to airborne contaminants such as particles, gases or vapors. The EN-149 masks are classified in three classes (FFP1, FFP2 and FFP3) depending on the ability to separate air-borne particles.

FFP3 respirator mask would filter out at least 98% of the airborne respirable particles, whereas an FFP1 respirator mask would filter out at least 80% of the respirable particles. FFP3 respirator masks are, therefore, the most efficient in filtering out fine particles including viruses, mold spores, and asbestos.

Medical Device Essential Requirements
Device Type Essential Technical Requirement Relevant Standards
FFP3 Valved/Unvalved Design and Performance:
  • Mask covers the nose and mouth and the chin and may have inhalation and/or exhalation valve(s). The mask consists entire-ly or substantially of filter material
  • Should have 2 elastic straps (may be adjustable) that go around the head and neck
  • Shall be offered for sale packaged in such a way that they are protected against mechanical damage and contamination be-fore use
  • Manufacturer must have quality management system in place such as evidence of compliance to ISO 9001 or BS EN 13485

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