Guangzhou Powecom KN95 Respirator – CDC Tested and FDA Whitelisted, 10-Pack

Guangzhou Powecom KN95 Respirator – CDC Tested and FDA Whitelisted, 10-Pack

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Description

Guangzhou Powecom KN95 Respirator – CDC Tested and FDA Authorized

(as of 5/7/2020 FDA Appendix A)

10 pack set of KN95 Particulate Respirator Mask.  Manufactured by Guangzhou Powecom.  One of last 15 FDA Authorized KN95 respirator mask manufacturers as of 5/7/2020 FDA Appendix A list under Emergency Use Authorization.

Product Features

  • Material: high-density non-woven fabric.
  • Filtering Rate: 95%
  • Protection Class: KN95
  • One size fits all
  • Multilayer protection,can filter out dust, germs, smoke, pollution and almost 95% particles in the air.
  • 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 Appendix A

On 5/7/2020, the FDA removed more than 60 respirator manufacturers off of their EUA Appendix A list after they decided to use the results of NPPTL testing as an additional criteria for being on the EUA Appendix A list.  These tests were done in mid-April and found that many KN95 respirators were not meeting the standards required to be labeled KN95.  Please find below links to FDA EUA Appendix A*, CDC website showing testing results for all KN95 respirators tested*** and NIOSH document showing the testing results for Guangzhou Powecom Resipirators***.

*FDA Appendix A List (https://www.fda.gov/media/136663/download)

**CDC NPPTL NIOSH-Modified Testing Results for All KN95 Respirators Tested (https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html)

***CDC NPPTL NIOSH-Modified Testing Results for Guangzhou Powecom KN95 (https://www.cdc.gov/niosh/npptl/respirators/testing/results/MTT-2020-49.1_International__PowecomKN95_TestReport_Redacted-508.pdf)

 

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