Cleared Abbreviated

ACTIPROTECT UC N95 RESPIRATOR (K093189) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K093189 · Glaxosmithkline Consumer Healthcare · General Hospital
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Jul 2010
Decision
266d
Days
Class 2
Risk

K093189 is an FDA 510(k) clearance for the ACTIPROTECT UC N95 RESPIRATOR. Classified as N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies (product code ORW), Class II - Special Controls.

Submitted by Glaxosmithkline Consumer Healthcare (Parsippany, US). The FDA issued a Cleared decision on July 2, 2010 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6260 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Glaxosmithkline Consumer Healthcare devices

Submission Details

510(k) Number K093189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2009
Decision Date July 02, 2010
Days to Decision 266 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ORW N95 Respirator With Antimicrobial/antiviral Agent For Use By The General Public In Public Health Medical Emergencies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6260
Definition A Single Use, Disposable, Niosh-approved N95 Respirator Intended For Use By The General Public In Public Health Medical Emergencies 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.