KN95 Respirator – FDA Registered, CE Tested and CE Certified, 20-Pack

KN95 Respirator – FDA Registered, CE Tested and CE Certified, 20-Pack

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Description

KN95 Respirator – FDA Registered, CE Tested and CE Certified

Pack of 20 or Pack of 80 – In Stock NOW, Ships from California, USA

KN95 Particulate Respirator Masks.  Manufactured in China by Guangzhou Kangling.  This product was CE Tested and CE Certified for use in Europe as a FFP2 (Europe EN 149-2001) qualified device.  These masks have not been tested by the CDC NPPTL and does not appear on the most recent FDA EUA Appendix A list.

Product Features

  • Material: high-density non-woven fabric.
  • Filtering Rate: > 94%
  • Protection Class: FFP2, KN95
  • One size fits all
  • Multi-layer protection, can filter out dust, germs, smoke, pollution and almost 95% particles in the air.
  • 4 Layers of Protection
    • Waterproof Non-Woven Fabric
    • Filtering Melt-Blown Cotton Layer
    • Electrostatic Filter Hot Air Cotton Layer
    • Skin Friendly Non-Woven Fabric Layer
  • Adjustable nose bridge and elastic earloop has enough elasticity to make a good seal.
  • 3D three-dimensional design with fluffy, breathable and soft, will not cause the fog when wearing glasses.
  • Not meant for medical use.
  • Made in China, Imported under FDA Non-NIOSH-Approved Disposable Filtering Facepiece Respirators EUA

How do KN95 Masks Work?

All KN95 masks have at least 4 layers of protection and filtration.  First, the outer layer is a waterproof non-woven fabric that filters out most larger dust particles.  The next layer is the characteristic KN95 melt-blown cotton layer that only allows the smallest particles through, generally less than .5 microns.  The next layer is an electrostatic hot air cotton layer that looks like a bunch of fibers woven together.  These fibers will attract and trap the smallest bacterial and viral particles with electrostatic energy and filter them out of the air moving through the mask.  The final inner layer is a skin friendly, moisture wicking non-woven fabric that is made mostly for comfort and protection from the inner layers of the mask where the particles will get stuck.

Additional Info

On March 2, 2020, the Secretary of Health and Human Services declared that circumstances exist to justify the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak.  April 3, 2020, the FDA issued an EUA to authorize the use of respirators manufactured in China that had not yet been approved by the CDC’s NIOSH branch.  Immediately after these actions, KN95 respirators began to ship en mass from China to the United States. On April 30, 2020, all KN95 masks imported from China were required to have a label that said they were not for medical use.

This lot of KN95 masks arrived here under the original EUA and was registered with the FDA.  These masks had previously been approved by Europe and was tested and certified with a CE Mark under their FFP2 protection class.

Kangling KN95 CE Test Reports

These masks were not tested by CDC NPPTL and therefore did not make the May 7, 2020 FDA EUA Appendix A list.

Internal Testing

We cut and test all of our KN95 masks to ensure that it has all four layers of typical KN95 masks.  The Two Non-Woven Fabric outer layers should melt when subjected to flame test.  They should also be waterproof so water should bead up when dropped onto the surface of the mask.  Melt-Blown Cotton layer should also melt with lighter flame and should look like interwoven fibers.  Electrostatic Hot Air Cotton Layer should pick up paper confetti to show that it is negatively charged and will attract small bacterial of viral particles.  While we don’t have the ability to do the CDC NPPTL test, we felt confident that the presence of these layers indicated that these KN95 masks were still effective with greater than 94% filtration.  However, we cannot guarantee that result.

Additional Resources

Definition of Acronyms:

  • FDA – United States Food and Drug Administration
  • CDC – United States Center for Disease Control
  • OSHA – Occupational Safety and Health Administration (Department of Labor)
  • NIOSH – National Insititute for Occupational Safety and Health (Division of CDC)
  • NPPTL – National Personal Protective Technology Laboratory (Division of CDC)
  • EUA – Emergency Use Authorization

International Respirator Performance Standard Abbreviations for Respirators that meet filter performance of greater than 94%

  • N95 (United States NIOSH-42CFR84)
  • FFP2 (Europe EN 149-2001)
  • KN95 (China GB2626-2006)
  • P2 (Australia/New Zealand AS/NZA 1716:2012)
  • Korea 1st Class (Korea KMOEL – 2017-64)
  • DS2 (Japan JMHLW-Notification 214,2018)

Reference document from 3M