Yes, N95FaceMasks are considered as class II devices regulated by the FDA. These masks are used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material.
Implemented ISO 13485 and approved N95 Face Mask is enough to be considered as FDA approved class II devices. Generally, class II devices must receive premarket clearance from the FDA under section 510(k) Clearances. However, N95s are exempt from this 510(k) Clearance requirements according to the Memorandum of Understanding MOU 225-18-006.