ONT
6 FDA 510(k) clearances · Product code
284 daysmedian time to decision
736 days90th percentile
6clearances measured
FDA profile
- Official device name
- N95 Respirator With Antimicrobial/Antiviral Agent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- FDA definition
- A single use, disposable, NIOSH-approved respirator intended for occupational use 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SpectraShield 9500 Surgical N95 Respirator (K150729) | Nexera Medical, Inc. | 2015-12-29 |
| BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR (K122702) | Filligent Limited | 2013-03-18 |
| SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR (K120244) | Nexera Medical, Inc. | 2012-07-05 |
| SPECTRASHIELD 9500 SURGICAL MASK (K090414) | Nexera Medical, Inc. | 2011-02-24 |
| ACTIPROTECT UF N95 RESPIRATOR (K093161) | Glaxosmithkline Consumer Healthcare | 2010-05-10 |
| ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD (K081923) | Glaxosmithkline Consumer Healthcare | 2009-07-01 |
Track ONT automatically
Every clearance here is in the API, with alerts when new ones post.