3M Respirators in International Packaging Made Available in US during COVID-19

FEMA will be distributing these respirator models to state authorities, and the states will determine distribution.

These respirator models hold various different approvals, including, in some cases, NIOSH N95. This product table(PDF, 546.30 KB) indicates which approvals are held by each model that FEMA is acquiring and distributing. See the 3M Technical Bulletin Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes(PDF,152.92 KB) for additional information concerning the similarities and differences between these approvals, all of which incorporate testing for filtration efficiency and inhalation and exhalation resistance.

KN90 respirators are respirators that meet a China government standard that requires lower filtration efficiency performance (at least 90%) than NIOSH N95 (at least 95%). While KN90 respirators are a form of respiratory protection, the amount of exposure reduction they are designed to provide is lower than the minimum amount that U.S. OSHA and NIOSH associates with the filtering facepiece class of respirators. Therefore, it is recommended that the use of KN90 respirators be considered a Crisis Capacity Strategy and that they be used where masks would otherwise be used, per the CDC prioritization table titled “Suggested facemask or respirator use, based upon distance from a patient with suspected or known COVID-19 and use of source control” in the CDC’s Crisis Capacity Strategies for Optimizing the Supply of N95 Respirators.

FEMA is shipping these respirators directly from 3M facilities in Asia and they will arrive in their Asia packaging. The model number will be printed on the packaging and the respirator. The user instructions can be found in this document: 3M Respirators in International Packaging Made Available in US during COVID-19

Consistent with FDA direction, FEMA and 3M will take steps to try to ensure that English User Instructions are provided to organizations receiving these respirators, including posting User Instructions for these respirators here: 3M Respirators in International Packaging Made Available in US during COVID-19 (PDF, 96.38 KB).

Several of the respirator models that FEMA is acquiring and distributing have a construction called “vertical flatfold,” which is not usually seen in the U.S. These respirators are packaged flat, with a vertical fold through the middle, but open up into a cup shape. Like the cup-style and horizontal flatfolds that are usually sold in the U.S., these imported models have two bands and a metal noseclip. The noseclip is folded in half at the top of the facepiece. The first step in putting on these respirators is to open the facepiece into a cup shape. After that, donning (putting on) the respirator follows steps similar to those for cup-style and horizontal flat-folds. As these respirators are designed for people with facial features common in China and Asia, they may not fit as well as respirators intended for sale and use in the US. Therefore, users must be fit tested before use. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator. Some FEMA-imported respirator models are the same as models that are common in the U.S. but will be in packaging with Asian languages.

In the U.S., earloops are often seen on masks but not on NIOSH-approved respirators, which typically have head bands. In some countries outside the U.S., however, it is more common for respirators to feature earloops. In countries outside the US, 3M does manufacture some certified respirators which feature earloops. Among the models being imported by FEMA are several models that feature earloops. Information about which respirator models contain earloops can be found in this product table(PDF,546.30 KB). NIOSH states “limited assessment of ear loop designs indicate difficulty achieving a proper fit. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved.” As these respirators are designed for people with facial features common in China and Asia, they may not fit as well as respirators intended for sale and use in the U.S. Therefore, users must be fit tested before use. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator.

User Instructions, training videos, and donning posters can be found in this product table (PDF, 546.30 KB).

U.S. Occupational Safety and Health Administration (OSHA) respiratory protection standards mandate that individuals using new respirator models receive training and a fit test prior to the first time they use a respirator. In addition, individuals should read and follow all user instructions, including conducting a user seal check every time they put on a respirator.

3M respirators acquired by FEMA in Asia are fit tested the same way as N95 respirators typically sold and used in the U.S. – with qualitative fit testing using BitrexTM or saccharin, as well as quantitative fit testing using a TSI PortaCount® being acceptable. Respirator fit testing resources can be found on the 3M website.

These respirators were designed to fit people with facial features common in China and other countries in Asia. As a result, some individuals with different facial features may not be able to achieve a satisfactory fit. U.S. customers may experience fit test passage rates that are lower than they are accustomed to. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator.

The 3M respirators that FEMA is acquiring from 3M in Asia will be distributed by FEMA to the States, free of charge. If you receive a respirator that is one of the model numbers identified above and was distributed for free and can be traced to a FEMA source of supply, it is more likely to be an authentic 3M product. FEMA is the only entity that is acquiring significant quantities of 3M respirators directly from 3M in Asia and then importing and distributing those models of respirators in the United States. If still unsure, contact the 3M fraud hotline at 1 (800) 426-8688. We take fraudulent activity very seriously. Please report such activity immediately. For additional information, see Fraudulent Activity, Price Gouging, and Counterfeit Products (PDF, 122.39 KB).

Several U.S. government agencies have issued temporary authorizations relevant to filtering facepiece respirators (FFRs) approved to other countries’ standards, which authorize those respirators to be used in U.S. healthcare settings even though such use would normally not be permitted.

In its Strategies for Optimizing the Supply of N95 Respirators, the U.S. Centers for Disease Control and Prevention (CDC) has recommended that healthcare institutions that no longer have access to any N95 respirators consider alternative respirators that are approved by other countries for occupational use and are similar to N95 respirators. Similar respirators include those approved to the following standards: Australia / New Zealand P2, China KN95, Japan DS2, and Korea Special 1stClass.

On March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an EUA that addresses the use of respirators approved to other countries’ and region’s standards during the public health emergency due to COVID-19, including those of Australia, Brazil, Europe, Japan, Korea and Mexico. On April 3, 2020, the FDA issued a second EUA that addresses respirators approved to the China standards.

The U.S. Occupational Safety and Health Administration (OSHA), the agency that regulates the selection and use of respirators in the workplace (PDF, 1.15 MB), states that only NIOSH-approved respirators may be used by U.S. workers (PDF, 1.15 MB). However, OSHA has issued an Enforcement Memorandum that indicates that during the COVID-19 pandemic and the resultant shortage of respiratory protection equipment, if employers have exhausted all other options to reduce exposures and explored alternative respiratory protection options, then it is preferred that respirators approved to other countries’ standards be used, rather than masks or other items that are not designed to provide exposure reduction.

The China KN90 approval is not considered similar to the U.S. NIOSH N95 approval by the US CDC and US OSHA.

Several 3M filtering facepiece respirator (FFR) models have been included in Exhibit 1 to the March 28 EUA and Appendix A to the April 3 EUA. Not all respirator models on these lists are currently being imported into the United States.