The model 9500-N95 is a NIOSH approved respirator. This respirator is also cleared by the FDA for surgical use. The quality certificate inside the box may display non-medical on it, but that is due to the regulations of the origin country (NIOSH approval number is: 84A-5411). This pack contains 4 boxes with 20 masks per box. For medical use Cup-style respirator Latex-free Medium/large Staple-free Lightweight construction NIOSH 95 and FDA cleared surgical respirator Adjustable nose clips and overhead straps Makrite 9500 80-Pack N95 NIOSH Respiratory Mask FDA Cleared for Surgical Use