Product code ONT— General, Plastic Surgery
ACTIPROTECT UF N95 RESPIRATOR
- Classification name
- N95 Respirator With Antimicrobial/Antiviral Agent
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 6
- First cleared
- Most recent
FDA classification 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.”
Market context for product code ONT
FDA has cleared devices under product code ONT between 2009 and 2015, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2013
- 2012
- 2011
- 2010
- 2009
Top applicants under product code ONT
Recent clearances under product code ONT
- K150729 — SpectraShield 9500 Surgical N95 Respirator
- K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
- K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
- K090414 — SPECTRASHIELD 9500 SURGICAL MASK
- K093161 — ACTIPROTECT UF N95 RESPIRATOR
- K081923 — ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
Data sourced from openFDA. This site is unofficial and independent of the FDA.