FDA product code ORW: N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
ORW is the FDA product code for n95 respirator with antimicrobial/antiviral agent for use by the general public in public health medical emergencies. It is a Class II device, regulated under 21 CFR 880.6260 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under ORW. The average 510(k) review took 266 days (median 266).
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.
Classification
| Field | Value |
|---|---|
| Device name | N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies |
| Device class | Class II |
| Regulation | 21 CFR 880.6260 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ORW clearance
Top ORW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Glaxosmithkline Consumer Healthcare | 1 | 2010-07-02 |
Most recent ORW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093189 | Glaxosmithkline Consumer Healthcare | ACTIPROTECT UC N95 RESPIRATOR | 2010-07-02 | 266 |
Recalls for ORW devices
openFDA lists no recalls for product code ORW.
Frequently asked questions
What is FDA product code ORW?
ORW is the FDA product code for n95 respirator with antimicrobial/antiviral agent for use by the general public in public health medical emergencies. It is a Class II device, regulated under 21 CFR 880.6260 and reviewed by the General Hospital panel.
What device class is ORW?
Class II, regulation 21 CFR 880.6260. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORW?
Across 1 cleared submissions the average was 266 days from receipt to decision (median 266).
Which companies have the most ORW clearances?
Glaxosmithkline Consumer Healthcare (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORW
- Run a recall and safety report across every ORW manufacturer
- Watch product code ORW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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