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What is the difference between medical grade and non-medical grade disposable masks?

Medical Sciences Asked by Anthony X on August 29, 2021

One can buy a disposable product which appears identical to medical grade disposable surgical masks, but is not. The package or item description typically includes a clear indication that it is not medical grade.

These masks appear to be constructed in the same way and of the same materials as a medical mask (melt-blown middle layer).

What is it about these products that disqualifies them as medical grade?

Is that difference relevant to personal protection when selecting a mask for COVID-19 protection in non-medical everyday settings? Would it pertain to product performance? Are these products not sterilized? If not sterilized, is there any actual or potential health implication for the wearer?

Examples of the non-medical grade product available in local stores:

https://www.staples.ca/products/2980998-en-lanswe-disposable-non-medical-face-masks-50-pack

https://www.walmart.ca/en/ip/3-laye-disposable-mask/6000201457780

https://www.canadiantire.ca/en/pdp/disposable-3-ply-non-medical-face-masks-50-pk-3997520p.html

One Answer

Offhand it would appear that surgical masks of the type you have cited would be regulated by the US government if they were to be used in a medical setting. Check out this FDA page, you will see that masks to be used in medical setting must conform to 21 CFR 878.4040. It is entirely possible that there is no physical difference between the medical and non-medical surgical (loose fitting) masks, however if the manufacturer labels it as a medical device or apparel they may have to have an FDA approval. See FDA web site on surgical masks

Update: a wealth of information about the 'grades' and conformance/performance of so-called surgical masks can be found here ASTM

Answered by BobE on August 29, 2021

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