Face Masks, Including Surgical Masks, and Respirators for COVID-19

  • 2020-12-13
  • 942

         Face masks (including cloth face coverings), surgical masks, and respirators (filtering facepiece respirators, such as N95 respirators) intended for a medical purpose to assist in preventing the spread of infectious materials during the COVID-19 pandemic.

Powered respirators, such as powered air purifying respirators (PAPRs) Face shields

Non-health care use of face masks and respirators intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use.

The information provided may be useful to manufacturers and importers of face masks, surgical masks, and respirators, as well as health care facilities and health care personnel.

To help expand the availability of face masks (including cloth face coverings), surgical masks, and respirators, the FDA is providing certain regulatory flexibility for the duration of the COVID-19 public health emergency, as described in the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and has issued emergency use authorizations (EUAs) for face masks, surgical masks, and respirators that meet certain criteria. The FDA regularly updates its communications about face masks, surgical masks, and respirators, including the answers to frequently asked questions on this page. 

  The Basics on Face Masks, Surgical Masks, and Respirators:  the FDA regulates face masks, including cloth face coverings, and surgical masks as medical devices when they are marketed for medical purposes. Medical purposes include uses related to COVID-19, such as face masks to help stop the spread of disease, surgical masks, and surgical masks with antimicrobial/antiviral agents. Face masks marketed to the general public for general non-medical purposes, such as for use in construction and other industrial applications, are not medical devices. 

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