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.
3M Respirators in International Packaging Made Available in US during COVID-19 (PDF, 96.38 KB)
Respirators from Asia Imported and Distributed by FEMA (PDF, 115.88 KB)
3M Filtering Facepiece Respirators Imported to U.S. from Asia by FEMA (PDF, 546.30 KB)
3M 9502+ Particulate Respirator, User Instructions (PDF, 363.99 KB)
Non-NIOSH Approved Respirators
Emergency User Authorization (EUA) End User Information
The following 3M respirators are listed in Appendix A of the April 3rd, 2020 EUA title imported, “Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators Manufactured in China”. Users should read the information below for their model before use. Please
note these are also listed at 3M.com/coronavirus.
• 9552/9552V, 9502, 9542, 9542V
• 9501, 9501+/9501V+, 9505+, 9541, 9541V
• 8822 (AU), 8822 (K)
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). As mentioned in CDC's strategies for optimizing respirator supply, other countries approve respirators according to country-specific standards. These devices are evaluated using methods similar to those used by NIOSH and are still expected to provide adequate protection for healthcare personnel. Non-NIOSH-approved FFRs manufactured in China that have been confirmed by FDA to meet the criteria under the EUA are included below in Appendix A. Additionally, the FDA, in collaboration with CDC NIOSH, is increasing surveillance and sampling of all respirators imported from China - all respirator shipments from China that come into the U.S. will be subject to random sampling and testing by CDC NIOSH to determine whether the respirator meets the expected particulate filtration standards.