N95 Respirator With Antimicrobial/antiviral Agent
General, Plastic Surgery · 21 CFR 878.4040
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Nexera Medical, Inc.Dec 29, 2015
K150729 · SpectraShield 9500 Surgical N95 Respirator
- Filligent LimitedMar 18, 2013
K122702 · BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
- Nexera Medical, Inc.Jul 5, 2012
K120244 · SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
- Nexera Medical, Inc.Feb 24, 2011
K090414 · SPECTRASHIELD 9500 SURGICAL MASK
- Glaxosmithkline Consumer HealthcareMay 10, 2010
K093161 · ACTIPROTECT UF N95 RESPIRATOR
- Glaxosmithkline Consumer HealthcareJul 1, 2009
K081923 · ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD