NIOSH N95 vs. Surgical N95 (NIOSH + FDA 510K) – Makrite 9500

With cold and flu season approaching, we want to share some notes regarding FDA 510K Surgical N95 masks versus masks with only NIOSH approval. It may be hard to distinguish patients suffering from common flu ailments with those who are infected with COVID-19. For stronger protection, especially when fluid resistance is required, we highly recommend FDA 510K cleared Surgical N95 respirators. The graphic below, provided by 3M, shows a helpful overview of NIOSH approved N95 and FDA cleared masks.

“In times of shortage, only healthcare professionals who are working in a sterile field or who may be exposed to high velocity splashes, sprays, or splatters of blood or body fluids should wear these [surgical N95] respirators, such as in operative or procedural settings.” For other workers who will not be performing such surgical procedures and do not require protection from high-pressure streams of liquid, a standard non-surgical N95 (or similar) respirator can be worn to help reduce those workers’ exposure to patient-generated airborne viruses and bacteria. 

The FDA designation as a Surgical N95 requires both NIOSH N95 certification as well as FDA 510K clearance as a Surgical Mask. The clearance of a NIOSH approved N95 as a Surgical N95 by the FDA requires fluid penetration tests along with other criteria. The list of Surgical N95 as provided by the NPPTL/NIOSH may be found here (CDC.gov Link). 

Please be aware that all vendors with authentic product should be able to provide documentation for their specific lot of masks. Because of the scarcity of FDA 510K cleared Surgical N95, much of the stock readily available within United States is counterfeit/unauthorized product. If they are not able to provide this documentation, please be cautioned that it is likely counterfeit/unauthorized and of lower quality. 

US News has recently reported a crackdown on counterfeit masks, where 10% of the masks tested below the 95% particulate filtration standard. 

Face Filter USA proudly and reliably offers you NIOSH approved N95 with FDA 510K clearance as a Surgical N95 mask – the Makrite 9500, akin to the well-known 3M 1860 model Surgical N95 mask. You can find it in our shop here. We will provide lot specific authenticity documentation as needed upon request, please email support@facefilterusa.com.  

We are here to support you and hope you find this information helpful. Stay safe, and be well!

FACE FILTER USA