FDA Approves the Importation of Facepiece Respirators

As a response to the rapidly-growing issue of medical supply shortages across the United States, the Food and Drug Administration (FDA) has authorized the use of certain non-NIOSH-approved disposable filtering facepiece respirators (FFR).  

Personal Protective Equipment (PPE), especially N95 masks are tested and certified by the National institute for Occupational Safety and Health, which is a research group as part of the Centers for Disease Control and Prevention (CDC).  

In this case, the NIOSH provides safety standards that FFRs must comply with to be considered safe.

Under current circumstances, the FDA believes that these devices will serve a substantial and suitable purpose for protection during this period of shortage caused by the COVID-19 pandemic. Non-NIOSH approved masks are more widely available than those for use and circulation and meet Chinese standards instead of American.  

This means that the FDA will authorize the emergency use of authorized respirators for use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak.  

Some things to help indicate the classification of FFRs

Filter Performance - The filter of these masks is evaluated to measure the reduction in concentration of specific aerosols in air that passes through the filter.  

Test agent- They aerosol that gets generated during the filter performance test.

Total Inward Leakage (TIL) - The amount of a specific aerosol that enters a tested respirator facepiece through both, filter penetration and face seal leakage. All of this while the wearer performs a series of exercises in the test chamber.  

Inward Leakage (IL) - The amount of a specific aerosol entering the tested respirator facepiece, while the wearer breathes normally for 3 minutes in the test chamber.  

Pressure Drop - The resistance that air is subjected to as it moves through the medium- such as a respirator filter.

Do you have questions about how to import these FFR masks into the United States?  

Simply give us a call at (877) 909-7447 and one of our logisticians will help arrange it for you!