Surgical masks provide protection against large droplets, splashes or sprays of bodily or hazardous fluids. They do not provide the wearer with reliable protection from inhaling smaller airborne particles and are not considered respiratory protection. FDA regulates surgical masks as Class II devices and assesses them for liquid barrier protection among other things.
FDA does not object to the marketing and distribution of surgical masks in the healthcare setting without prior 510(k) clearance if the product meets the recommendations below. Please note that these recommendations only apply for the duration of the COVID-19 Public Health Emergency. This is because FDA recognizes the urgent need for PPE in the setting of the COVID-19 pandemic due to increased use and shortages in their availability.
- Meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity).
- Meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas); and
- When the labeling is consistent with the following:
• Described as a “surgical mask”;
• Does not include uses for antimicrobial or antiviral, protection or related uses;
• Does not include uses for infection prevention or reduction or related uses;
• Does not make particulate filtration claims; and
• Contains a list of the body contacting materials, which should not include any drugs or biologics.
Further, we have the following recommendations for marketing of face masks which do not meet the fluid resistance testing recommendation:
Guidance for Face masks:
Please note that these recommendations only apply for the duration of the COVID-19 Public Health Emergency.
FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:
- It states it may be used when FDA cleared masks are unavailable;
- It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
- It makes no claims of antimicrobial or antiviral protection;
- It makes no claims of infection prevention or reduction;
- It makes no claims regarding flammability
- The labeling contains a list of the body contacting materials.
- The mask is not labeled as a “surgical mask”; rather it may be labeled as a “face mask”
In addition, FDA does not object to marketing face masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.
Centers for Disease Control and Prevention (CDC) released updated facemask guidelines, now suggesting that all Americans wear masks or face coverings in public. This follows a number of other health care professionals and state leaders recommending the same. It is critical we reserve medical supplies for healthcare workers who are working on the front-lines.