# K093189: Actiprotect UC N95 Respirator

- Pathway: 510(k) (Abbreviated)
- Applicant: Glaxosmithkline Consumer Healthcare
- Decided: Jul 2, 2010 after 266 days
- Product code: ORW (N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies)
- Device class: 2
- Regulation: 21 CFR 880.6260
- 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.
- DEN060009: 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator, 3M Company (2007). Our reading of the summary gave K062070, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060009, 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home… (3M Company), granted May 8, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
ActiproteCt' TM UC 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 (including 2009 pandemnic 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 A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN13612007, including 2009 pandemnic strain: NYMO X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN11212007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey AN~isc/68, Myna AIMass/71), and Influenza 8 strains (JPN18512007, JPN/1 28/2007, JPN114312007)) 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'T is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemnic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect~m UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.

Source page: https://510kreport.com/device/K093189
Methodology: https://510kreport.com/methodology