510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN060009Unknown

3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator

3M Company, St. Paul MN / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN060009 is the FDA 510(k) clearance record for 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR, a class II device, cleared for 3M Company on under FDA product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies). FDA's definition for product code NZJ 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...". FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming DEN060009.

Clearance record

Decision date
Received
(217 days to decision)
Product code
NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Regulation
21 CFR 880.6260
Device class
Class II
Review panel
General Hospital
Applicant
3M Company 3m Center, Bldg. 275-5w-06, St. Paul MN
Third party review
No

Clearances, product code NZJ

Trailing 12 months

FDA records hold no clearances under product code NZJ in the trailing twelve months.

FDA records show no clearances under product code NZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260