Cleared Abbreviated

K093179 - MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)

K093179 is an FDA 510(k) clearance for MEDICAL SURGICAL MASK (HH1001), manufactured by H&H Research Company. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 279-day FDA review.

K093179 · H&H Research Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
279d
Days
Class 2
Risk

K093179 is an FDA 510(k) clearance for the MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by H&H Research Company (Los Angeles, US). The FDA issued a Cleared decision on July 14, 2010 after a review of 279 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.

FDA 510(k) Submission Details - K093179

510(k) Number K093179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date July 14, 2010
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
Pathway characteristics
Standards-based clearance path.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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.

Regulatory Peers - FXX Mask, Surgical

All 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K093179.
SURGICAL FACE MASK
K093901 · Epard Protective Products, Ltd. · Sep 2010
IMC SURGICAL FACE MASK
K100846 · International Medsurg Connection · Aug 2010
WELLMIEN SURGICAL MASK
K101000 · Wellmien (Suzhou) Import & Export Trading Co., Ltd. · Aug 2010
TIDI FACEMASK
K100800 · Tidi Products,Llc · Jun 2010
TIDI FACEMASK
K092580 · Tidi Products,Llc · Feb 2010
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
K092012 · Primed Medical Products, Inc. · Sep 2009
K093179 · MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
Download PDF FDA Summary H&H Research Company