Scribd
Upload
29 views1 page

RE: U.S. Emergency Use Authorization (April 3 EUA)

This letter discusses 3M respirator models 9001/9002 that were imported from China in response to shortages caused by COVID-19. The FDA issued an emergency use authorization on April 3rd allowing the use of these China KN90-approved respirators by healthcare workers in the US. While KN90 standards differ slightly from N95, these respirators can help reduce exposure to airborne particles when properly selected, worn, and accompanied by required training and seal checks. Users should contact 3M if any adverse events occur.

Uploaded by

Bernard
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
29 views1 page

RE: U.S. Emergency Use Authorization (April 3 EUA)

This letter discusses 3M respirator models 9001/9002 that were imported from China in response to shortages caused by COVID-19. The FDA issued an emergency use authorization on April 3rd allowing the use of these China KN90-approved respirators by healthcare workers in the US. While KN90 standards differ slightly from N95, these respirators can help reduce exposure to airborne particles when properly selected, worn, and accompanied by required training and seal checks. Users should contact 3M if any adverse events occur.

Uploaded by

Bernard
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 1

Date: April 9, 2020

RE: U.S. Emergency Use Authorization (April 3 EUA)

Dear Valued Customer,

This letter relates to the use of the following 3M filtering facepiece respirators (FFR) that have been imported from China in
response to the FFR shortage resulting from the COVID-19 outbreak: 9001/9002.

In its Strategies for Optimizing the Supply of N95 Respirators1, the U.S. Centers for Disease Control and Prevention (CDC)
has recommended that health care institutions that no longer have access to NIOSH-approved N95 respirators consider
respirators approved under standards used in other countries that are similar to NIOSH approved N95 filtering facepiece
respirators for occupational use.

On April 3, 2020, the U.S. Food and Drug Adminstration (FDA) issued an Emergency Use Authorization (April 3 EUA)2
that addresses the use by healthcare personnel in the United States of respirators manufactured and approved in China.
Pursuant to the April 3 EUA, the 3M respirator models listed above are intended to be used on an emergency basis in
accordance with CDC recommendations to help prevent healthcare personnel exposure to pathogenic biological airborne
particulates during filtering facepiece respirator (FFR) shortages resulting from the COVID-19 outbreak.

The 3M respirator models listed above are China KN90-approved. The classification of KN-90 differs from KN-95 in that
the filter penetration allowance is 10% (rather than 5% for KN-95) and the total inward leakage test allowance is less than
or equal to 11% (rather than 8% for KN-95).3 More information about these approvals and respirators – including User
Instructions – is available at: www.3M.com/Coronavirus.

When properly selected and worn, these respirators help reduce exposure to airborne particles, including biological aerosols
that may contain viruses or bacteria. The respirators listed above were designed to fit people with facial features common
in China and Asia. OSHA respiratory protection standards mandate that individuals using new respirator models receive
training and a fit test prior to the first time they use the respirator. In addition, individuals should read and follow all user
instructions, including conducting a user seal check every time they put on a respirator.

If you experience any adverse events associated with the use of these respirators, please contact the 3M PSD
Technical Service 1 (800) 243-4630.

1
Strategies for Optimizing the Supply of N95 Respirators published by U.S. Centers for Disease Control and Prevention (last accessed April 6, 2020)
2
April 3, 2020 Emergency Use Authorization published by U.S. Food & Drug Administration (last accessed April 6, 2020)
3
Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes published by 3M (last accessed April 6, 2020)

Personal Safety Division In the United States of America


Technical Service: 1 (800) 243-4630

3M Center, Building 235-2W-70 Customer Service:


3M.com/workersafety
1 (800) 328-1667

St. Paul, MN 55144-1000 In Canada


Technical Service: 1 (800) 267-4414
Customer Service: 1 (800) 364-3577
3M PSD products are for occupational use only. 3M.ca/safety

You might also like