ORWClass II

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

21 CFR 880.6260 / General Hospital

ORW is the FDA product code for N95 Respirator With Antimicrobial/Antiviral Agent 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: "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 particulates and has an added antimicrobial and/or antiviral agent which kills specified...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2010-07-02, and no recalls.

Classification record

Product code: ORW
Device name: N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
FDA definition: 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 particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
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: 1
Ingested recalls: 0

Clearances, product code ORW

By decision year

1 clearance under product code ORW with a decision year between 2010 and 2010, 2010 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code ORW by decision year
Year	Clearances
2010	1

Applicants with the most clearances

Product code ORW

Applicants holding the most 510(k) clearances under product code ORW
Applicant	Clearances
Glaxosmithkline Consumer Healthcare	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ORW.

Recent clearances

Product code ORW

K093189Class IIActiprotect Uc N95 RespiratorGlaxosmithkline Consumer Healthcare / cleared 2010-07-02

Recent recalls

Product code ORW

FDA records show no recalls under product code ORW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)