DeviceClearance

Product code NZJ— General Hospital

3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE

Classification name
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Device class
Class 2
Regulation
21 CFR 880.6260
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.”

— U.S. Food and Drug Administration, device classification record for product code NZJ under 21 CFR 880.6260, via openFDA

Market context for product code NZJ

FDA has cleared 2 devices under product code NZJ between 2007 and 2009, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NZJ

Recent clearances under product code NZJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.