|Country Of Origin||Taiwan|
3M KN90 Protective Face Mask 9001 – With Elastic Ear Loops
- Comfort Wear with Straps for Around the Ears
- High-Efficiency Electrostatic Cotton
- Soft Lining Gives Added Comfort and Durability
- Contour Molded Nose Bridge All ProductsMessenger
3M Respirators in International Packaging Made Available in US during COVID-19
3M is continuing to address the COVID-19 pandemic with many tactics to help protect those responding to the outbreak, including healthcare workers and first responders. In early April, 3M reached agreement with the U.S. government on a plan that, with the Trump Administration’s assistance, will enable FEMA to import 166.5 million respirators into the United States over a 3-month period starting in April, from our plants in Asia.
Read this if you have received 3M respirators in international packaging
The Food and Drug Administration requires this information be made available to everyone who has received these respirators.
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China (Reissued October 15, 2020)
On April 3, 2020, the FDA issued an umbrella EUA for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the National Institutes of Occupational Safety and Health (NIOSH). Respirator models authorized by this EUA are listed in Appendix A and are authorized for emergency use by healthcare personnel in healthcare settings in accordance with CDC recommendations. Summaries of FDA’s reissuances of this EUA follow.
As part of the federal government’s continuous quality assessment of these respirators, the FDA, working with CDC’s NIOSH, conducted additional assessments and found that NIOSH’s data indicated that some of the respirators authorized under the April 3, 2020 EUA did not meet the expected performance standards. In response, the FDA revised and reissued the EUA on May 7, 2020, including revising the third eligibility criterion such that all respirators that were previously authorized only under that criterion were no longer within the scope of authorization and were accordingly removed from Appendix A unless the respirator model was authorized under one of the remaining eligibility criterion in the May 7th letter. Additionally, the FDA, in collaboration with CDC’s NIOSH, increased surveillance and sampling of all respirators imported from China. All respirator shipments from China that come into the U.S. are subject to random sampling and testing by CDC’s NIOSH to determine whether the respirator meets the expected particulate filtration standards.
On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated.
On October 15, 2020, the FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. As of October 15, 2020, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria. *Further explanation of the current EUA can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Facepiece Respirators.
- EUA Letter of Authorization – Umbrella EUA: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (Reissued October 15, 2020)
- Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA FAQs
- Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China (Updated October 15, 2020)
- Respirator Models No Longer Authorized (Updated October 15, 2020)
* Please note that the Appendix A list may be updated periodically to reflect administrative changes (for example, inclusion of a link to the instructions for use) or respirator model removal.
Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated with Administrative Changes or Respirator Model Removals: October 15, 2020.)
The table below includes a list of non-NIOSH-approved respirator models manufactured in China that are authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
As stated in the EUA, authorized respirators are authorized for use by healthcare personnel in healthcare settings in accordance with the CDC’s recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC’s webpage: Strategies for Optimizing the Supply of N95 Respirators.