510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NZJClass II

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

21 CFR 880.6260 / General Hospital
FDA source (opens on fda.gov)

NZJ is the FDA product code for Respirator, N95, For Use By The General Public In Public Health Medical Emergencies, a class II device type, regulated under 21 CFR 880.6260. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NZJ
Device name
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
FDA 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.
Regulation
21 CFR 880.6260
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
2

Clearances, product code NZJ

By decision year
2 clearances under product code NZJ with a decision year between 2007 and 2009, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NZJ by decision year
YearClearances
20071
20091

Applicants with the most clearances

Product code NZJ
Applicants holding the most 510(k) clearances under product code NZJ
ApplicantClearances
3M Company1
Pasture Pharma Pte Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code