Cleared Traditional

ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD (K081923) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081923 · Glaxosmithkline Consumer Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
359d
Days
Class 2
Risk

K081923 is an FDA 510(k) clearance for the ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD. 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 July 1, 2009 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Glaxosmithkline Consumer Healthcare devices

Submission Details

510(k) Number K081923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date July 01, 2009
Days to Decision 359 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 129d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.