Procedure and surgical masks

FDA regulates surgical masks as medical devices under 21 CFR 878.4040; a general-use face mask is not personal protective equipment. Masks fasten with ear loops or ties, and some carry an attached eye shield; the label, not the product name, tells you what you’re buying.

Where a manufacturer states an ASTM F2100 level, the listing shows it exactly as stated, with the figures behind it: bacterial filtration efficiency (BFE), sub-micron particulate filtration efficiency (PFE), fluid resistance in mmHg, and breathability as differential pressure. Compare those figures, not the mask’s color or name. Which level a task calls for is your facility’s decision.

Each listing also shows the number of layers, the nose piece, any attached eye shield, the latex statement and any FDA 510(k) number, as the manufacturer gives them, with masks per box and boxes per case.

We carry procedure and surgical masks from Halyard and Medline.