What Is This Device?
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.
How Is NZJ Classified?
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies is FDA product code NZJ, Class 2, 21 CFR 880.6260.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2020. None was by a company in China. The root cause the FDA records most often is Manufacturing material removal (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.