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Re-Usable Half Mask

Reusable twin-filter half-face mask with A2P3 combination filters that offers low breathing resistance.

Description

Comprising a reusable face mask with added safety goggles, the GVS Elipse Integra P3 half-face respirator mask is ideal for everyday use for respiratory protection against dust, metal fumes and airborne micro-organisms. Manufactured from a comfortable TPE and featuring an elasticated head and neck strap, this dust mask is suitable for wearing over long periods of time with a reduced risk of wearer fatigue.

Medical Device Essential Requirements
Device Type Essential Technical Requirement Relevant Standards
Re-Usable Half Mask Respirator
– Particle Filter
Design and Performance:
  • Mask covers the nose and mouth and the chin and has one or more replaceable P3 particle filters
  • Should have adjustable straps 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 before use
  • Manufacturer must have quality management system in place such as evidence of compliance to ISO 9001 or BS EN 13485
Note: P3 filters are separate consumable and must be compatible with the model of respirator. This will usually be stated on the information provided with the mask/filter.
Marking and Packaging Requirements: as specified in BS EN 140:2001 and BS EN 143:2000
Manufacturer’s Instructions and Information to be provided: as specified in BS EN 140:2001 and BS EN 143:2000

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