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.
Makrite 9500 Features:
- FDA Cleared NIOSH Approved
- FDA 510(K) Clearance: K020474
- NIOSH Approval: TC-84A-5411
- 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
They are extremely durable with a soft and comfortable inner surface, also have an adjustable nose piece and secured head straps to provide proper fit. These masks have a 510(K) number for the medical market and can be used TB situations as recommended by OSHA.