Q: Are face masks regulated?
A: Face masks and respirators used by health care workers in medical settings are considered medical devices, and thus are regulated by the Food and Drug Administration and other agencies to ensure they meet a set standard.
But face masks that are marketed to the general public are not considered medical devices, and thus don’t have to meet any specifications before they can be sold.
The facial coverings marketed to the general public aren’t currently regulated or reviewed by a strict set of criteria or standards, meaning different facial coverings may provide varying degrees of protection depending on what they are made of and how they are constructed.
A group of industry professionals led by ASTM International is working to create a uniform set of standards so consumers can know how much protection a given mask offers before they purchase it, according to a report in the Washington Post.
Absent stringent regulations, public health experts recommend people use a face mask that fits comfortably and one that they will wear, and ideally one that has at least two layers of fabric.