Surgical face masks are cleared by the US Food and Drug Administration (FDA)
as medical devices. FDA notes that “surgical masks are not intended to be used
more than once. If your mask is damaged or soiled, or if breathing through the
mask becomes difficult, you should remove the face mask, discard it safely, and
replace it with a new one.”
According to the Food and Drug Administration a single-use device, also
referred to as a disposable device, is intended for use on one patient during a
single procedure. It is not intended to be reprocessed (i.e., cleaned and
disinfected or sterilized) and used on another patient. If a device does not have
reprocessing instructions, regardless of labeling, it should be considered
single-use and disposed of appropriately (i.e., according to federal, state, and
local regulations) after one use.
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