ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD— 510(k) K081923

Name: FDA 510(k) clearance K081923
Creator: U.S. Food and Drug Administration
Published: 2009-07-01

Substantially Equivalent

Glaxosmithkline Consumer Healthcare

FDA 510(k) clearance K081923 for ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD, Substantially Equivalent on 2009-07-01. Applicant: Glaxosmithkline Consumer Healthcare. Device class: 2.

Clearance details

Applicant: Glaxosmithkline Consumer Healthcare
Product code: Code ONT
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2008-07-07
Decision date: 2009-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONT

view all

K150729 — SpectraShield 9500 Surgical N95 Respirator2015-12-29
K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR2013-03-18
K120244 — SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR2012-07-05
K090414 — SPECTRASHIELD 9500 SURGICAL MASK2011-02-24
K093161 — ACTIPROTECT UF N95 RESPIRATOR2010-05-10

More clearances from Glaxosmithkline Consumer Healthcare

view all

K093189 — ACTIPROTECT UC N95 RESPIRATOR2010-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.