Cleared Traditional

K093901 - SURGICAL FACE MASK

K093901 is an FDA 510(k) clearance for SURGICAL FACE MASK, manufactured by Epard Protective Products, Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K093901 · Epard Protective Products, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
262d
Days
Class 2
Risk

K093901 is an FDA 510(k) clearance for the SURGICAL FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Epard Protective Products, Ltd. (Mosely, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 262 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 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K093901

510(k) Number K093901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date September 10, 2010
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K093901.
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
TIGER FLAT SURGICAL MASK
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CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
IMC SURGICAL FACE MASK
K100846 · International Medsurg Connection · Aug 2010
WELLMIEN SURGICAL MASK
K101000 · Wellmien (Suzhou) Import & Export Trading Co., Ltd. · Aug 2010
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
K093179 · H&H Research Company · Jul 2010
K093901 · SURGICAL FACE MASK
Download PDF FDA Summary Epard Protective Prod…