The model 9500-N95 is a NIOSH approved respirator. This respirator is also cleared by FDA for surgical use. The quality certificate inside the box may display non-medical on it, but that is due to the regulations of origin country (NIOSH approval number: 84A-5411). This comes in a pack of 20 respirators in a box. For medical use Cup style respirator Latex-free Medium/large Staple-free Lightweight construction promotes greater worker acceptance NIOSH 95 and FDA cleared surgical respirator Adjustable nose clips and overhead straps Foam Anti-Fog Nose Pads Makrite 9500-N95, NIOSH Respirator, FDA Cleared for Surgical, Pack of 20