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FFP2 Valved/Unvalved Mask

CE-certified and FDA-cleared FFP2 respirators confirmed to meet all European Standard requirements.


Our FFP2 respirators have been confirmed to meet all of the performance requirements set by the European Standard EN 149:2001+A1:2009. They are also completely CE-certified and FDA-cleared.

Our filtering face piece respirators can be used for respiratory protection against various non-oily airborne contaminants. They are extremely effective (94-99%) against tiny particulate matter of less than 0.3 and 2.5 microns in diameter (PM0.3 and PM2.5 respectively) among which are many infectious agents. For the purpose of protecting yourself from influenza viruses (SARS, avian flu, coronavirus, etc.), respirator masks were recommended as part of the PPE by the World Health Organization (WHO).

Medical Device Essential Requirements
Device Type Essential Technical Requirement Relevant Standards
FFP2 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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