N95 masks are protective masks that meet NIOSH
N95 certification.
"N" is Non-oil suitable for filtration of non-oil particles, not suitable for oily particles (oil smoke, oil extractor fumes, etc.); "95" means that the filtration efficiency is greater than 95%.
N95 mask is a class of masks collectively, the main target of the dust mask. You said the medical device class, generally if it is a medical protective mask, such as 3m1860 medical protective mask, if it is the sale, you need to provide a medical device license.
I don't know if I answered your question, but if you have any questions, keep asking.