By Marilyn Gatin, Min Yao, and Dorothy Henckel
As the COVID-19 pandemic unfolds, physicians, nurses, and other caregivers nationwide are facing a shortage of N95 respirators and face masks, putting the safety of patients and clinicians at risk.
The “N95” designation means that when subjected to careful testing, the respirator blocks at least 95% of very small (0.3 micron) test particles.
When an N95 respirator is labeled for use in a hospital setting, it is a Class II medical device regulated by the U.S. Food and Drug Administration (FDA). This is a surgical respirator with the product code MSH. According to 21CFR 878.4040:
Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter subject to 878.9, and the following conditions for exemption:
When an N95 respirator is labeled for occupational use it is regulated by NIOSH. Both types of respirators are evaluated by NIOSH. NIOSH approval criteria can be found here.