APPROVALS AND CERTIFICATIONS
- FDA approval: product code QKR
- Health Canada, Class I, PPE
- ≥95% BFE (Bacterial Filtration Efficiency)
- ≥95% PFE (Particle Filtration Efficiency)
- 3-layer protection with melt-blown middle layer for particle filtration
- nose clip
- earl loop
Homedics clearly states [homedics.com]
these are compliant with FDA standard QKR [fda.gov]
and are Level I in Canada. This means that these masks are appropriate for use in US or Canadian medical facilities/hospitals. These are not N95 or KN95 masks, and do not claim to be.
Homedics is an American company based in the US. The masks are made in China, but these being package/labelled/overseen by US company and US distributor, the FDA has strong oversight and the ability to take actions against American companies if they falsely advertise their masks. This is not the case with all these Chinese companies and distributors who have consistently either lied in their product labeling, or who have had their approvals yanked by the FDA (including 2 different KN95 masks I bought through this site). I'd rather buy something that is more than enough for my use in public, and that is what the manufacturer states it is.