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Surgical Masks

Updated: Sep 13, 2020

A surgical mask is a disposable device that creates a physical barrier between the mouth and the nose of the wearer from contaminants in the physical environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are for a one time use and are not to be shared. They may be labeled as surgical, isolation, dental, or medical procedure masks. They may also come with or without a face shield and these are often referred to as face masks. Not all masks are regulated under the regulations as surgical masks.

Surgical masks are made in a variety of thickness levels and different protection levels against contact with liquids. These properties may also affect the ease at which the wearer may breathe and how well the surgical mask protects you against contaminants. If worn properly, the surgical mask is meant to protect against large-particle droplets, splashes, sprays, or splatters that contain germs, viruses, and bacteria by keeping them away from your mouth and nose. Surgical masks may also help by reducing exposure of your own saliva and body fluids to others.

While a surgical mask may be effective in blocking large splatters, the face mask does not filter or block small particles in the air by design. They do not provide complete protection from germs and other contaminants because of the loose fit design of the mask.

Surgical masks are not intended for more than one usage. If your mask is damaged or soiled, or if breathing with the mask becomes difficult, it is best to remove it, discard it safely, and replace it with a new one. To safely discard of the mask, place it in a plastic bag and then throw it in the trash. Wash your hands thoroughly after handling the used mask.


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