# K093161: Actiprotect UF N95 Respirator

- Pathway: 510(k) (Abbreviated)
- Applicant: Glaxosmithkline Consumer Healthcare
- Decided: May 10, 2010 after 216 days
- Product code: ONT (N95 Respirator With Antimicrobial/Antiviral Agent)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922507 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold, Glaxosmithkline Consumer Healthcare (2009) Summary page 2.

## Indications for use
Actiprotect™ UF N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: Uitric acid, 1.8%, a pH lowering agent) and is not an antiviral ding. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes HI NI (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer layer of the respirator when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): HININ(JPN/35/2007, YPN/36/2007, including 2009 pandemnic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: HSNlI (VNH5N1I-PR8/CDCRG), H5N9 (Turkey AIWisc/68, Myna AIMass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for occupational use during seasonal influenza A or an influenza A pandemic. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during seasonal influenza A or an influenza A pandemic. Actiprotect™ UP N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Source page: https://510kreport.com/device/K093161
Methodology: https://510kreport.com/methodology