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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 pack contains 12 boxes with 20 masks per 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 Foam Anti-Fog Nose Pads Adjustable nose clips and Overhead Straps Makrite 9500-N95, NIOSH Respirator, FDA Cleared for Surgical, Pack of 240
