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:





1 Answer 1


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

  • 1
    Your answer assumes an American perspective. I'm in Canada; while we may take some assurance from an FDA approval, we have our own regulatory systems, as would any other country. Is it purely a matter of regulatory approval (and presumably traceability) in the jurisdiction of sale, and not an actual difference in materials, manufacturing, treatment and/or handling of the product?
    – Anthony X
    Commented Jul 19, 2020 at 15:39
  • quick google found this:"It is important for importers to be aware that face masks of all types for use in a medical setting are considered class I medical devices by Health Canada and a Medical Device Establishment Licence is required to import and distribute class I medical devices." This seems to suggest that Health Canada regulates surgical masks ** when employed in a medical setting**, in the same manner as US. Canada even goes so far as to regulate the importation... if it will be used as a medical device.
    – BobE
    Commented Jul 19, 2020 at 21:08

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service and acknowledge you have read our privacy policy.

Not the answer you're looking for? Browse other questions tagged or ask your own question.