510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093189Substantially Equivalent

Actiprotect Uc N95 Respirator

Glaxosmithkline Consumer Healthcare, Parsippany NJ / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093189 is the FDA 510(k) clearance record for ACTIPROTECT UC N95 RESPIRATOR, a class II device, cleared for Glaxosmithkline Consumer Healthcare on under FDA product code ORW (N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies). FDA's definition for product code ORW reads: "A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological...". FDA records list 4 510(k) clearances for Glaxosmithkline Consumer Healthcare, from to . As of , FDA records show no recalls naming K093189.

Clearance record

Decision date
Received
(266 days to decision)
Product code
ORW N95 Respirator With Antimicrobial/Antiviral Agent 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
Glaxosmithkline Consumer Healthcare 1500 Littleton Rd., Parsippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORW

Trailing 12 months

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

FDA records show no clearances under product code ORW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORW, 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