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Single Use/Disposable Mask

50pcs disposable face masks with 3-layer protection and adjustable ear loops

Description

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splat-ter that may contain vi-ruses and bacteria. Surgical masks may also help reduce exposure of the wearer's saliva and respiratory secretions to others.

Front View
Single Use/Disposable Mask
Slant View
Single Use/Disposable Mask
Side View
Single Use/Disposable Mask
Medical Device Essential Requirements
Device Type Essential Technical Requirement Relevant Standards
Type I
- Single Use/Disposable
(Not generally intended for use by NHS workers)		 Design and Performance:
  • Must provide a bacterial filtration efficiency (BFE) of 95% or above to be labelled Type I if tested to BS EN 14683
  • Must have differential pressure of less than 40Pa/cm2 to be labelled Type I if tested to BS EN 14683
  • Must fit closely over the nose, mouth and chin of the wearer. The use of deformable nose bands or nose bridges are rec-ommended which can enhance fit by conforming to the nose contours
  • Manufacturer must have quality management system in place with evi-dence of compliance to ISO 9001 or BS EN 13485 or equivalent
Label: See MDR Annex I – information to be supplied with the device and use of symbols in accordance internationally recognised symbols
  • Must indicate masks type of mask. 'Type I' (if it complies with BS EN 14683) or should state 'not fluid resistant' as appropriate
  • Should have an expiry date
 BS EN 14683:2019
Medical face masks. Requirements and test methods
or
ASTM F2100 minimum
Level 1
Type II
- Single Use/Disposable		 Design and Performance:
  • Must provide a bacterial filtration efficiency (BFE) of 98% or above to be labelled Type II if tested to BS EN 14683
  • Must have differential pressure of less than 40Pa/cm2 to be labelled Type II if tested to BS EN 14683
  • Must fit closely over the nose, mouth and chin of the wearer. The use of deformable nose bands or nose bridges are recommended which can en-hance fit by conforming to the nose contours
  • Manufacturer must have quality management system in place with evi-dence of compliance to ISO 9001 or BS EN 13485 or equivalent
 Label: See MDR Annex I – information to be supplied with the device and use of symbols in accordance internationally recognised symbols
  • Must indicate masks type. 'Type II' (if it complies with BS EN 14683) or should state 'not fluid resistant' as appropriate
  • Should have an expiry date
Type IIR
Fluid Resistant Surgical Mask (FRSM)
- Single Use/Disposable		 Design and Performance:
  • Must have a splash resistance pressure of 16.0 kPa (120mm Hg) or above to be labelled Type II if tested to BS EN 14683
  • Must provide a bacterial filtration efficiency (BFE) of 98% or above to be labelled Type IIR if tested to BS EN 14683
  • Must have differential pressure of less than 60Pa/cm2 to be labelled Type IIR if tested to BS EN 14683
  • Must fit closely over the nose, mouth and chin of the wearer. The use of deformable nose bands or nose bridges are recommended which can en-hance fit by conforming to the nose contours
  • Manufacturer must have quality management system in place such as evi-dence of compliance to ISO 9001 or BS EN 13485
 Label: See MDR Annex I – information to be supplied with the device and use of symbols in accordance internationally recognised symbols
  • Must indicate type of mask. 'Type IIR' (if complies with BS EN 14683) or should state fluid or splash resistant as appropriate if equivalent test for splash resistance has been carried out
  • Should have an expiry date

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