# K081923: Actiprotect UF N95 Respirator, Double Strap, Flat Fold

- Pathway: 510(k) (Traditional)
- Applicant: Glaxosmithkline Consumer Healthcare
- Decided: Jul 1, 2009 after 359 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: 6 generations back to K922507 (1992). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070782: Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models HC-NB095F and HC-NB295F, Survivair Respirators, LLC (2007) Summary page 2.

## Most influential descendants
- K093189: Actiprotect UC N95 Respirator (2010), 0 descendants of its own
- K093161: Actiprotect UF N95 Respirator (2010), 0 descendants of its own

## Indications for use
ActiprotectTM UF N95 Respirator is a single use, disposable respirator coated with VirucoatTM on the outer layer (active ingredient: citric-acid, .1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of influenza A viruses (tested against influenza A subtypes H1N1 (2009 pandemic strains not tested)) within one minute of contact with the surface of the respirator. In vitro testing has demonstrated 99.99% kill (inactivation) on the surface of the outer layer when tested in vitro against the following influenza viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, 2009 pandemic strains not tested), H2N2 (A2/JP/305157), H3N2 (Hong Kong 8/68) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and an Influenza B strain (JPN/85/2007)) under tested contact conditions. Correlation between in vitro activity and any clinical event has not been tested. ActiprotectTM 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. ActiprotectTM UF N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Source page: https://510kreport.com/device/K081923
Methodology: https://510kreport.com/methodology