Cleared Abbreviated

ACTIPROTECT UF N95 RESPIRATOR (K093161) - FDA 510(k) Clearance

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

K093161 · Glaxosmithkline Consumer Healthcare · General Hospital
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May 2010
Decision
216d
Days
Class 2
Risk

K093161 is an FDA 510(k) clearance for the ACTIPROTECT UF N95 RESPIRATOR. Classified as N95 Respirator With Antimicrobial/antiviral Agent (product code ONT), Class II - Special Controls.

Submitted by Glaxosmithkline Consumer Healthcare (Parsippany, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 216 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 K093161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2009
Decision Date May 10, 2010
Days to Decision 216 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
87d slower than avg
Panel avg: 129d · This submission: 216d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ONT N95 Respirator With Antimicrobial/antiviral Agent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Single Use, Disposable, Niosh-approved Respirator Intended For Occupational Use 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.