Cleared Traditional

K023755 - WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD

K023755 is an FDA 510(k) clearance for WINNER EAR LOOP PROCEDURE MASK, manufactured by Winner Industries (Shenzhen) Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K023755 · Winner Industries (Shenzhen) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
214d
Days
Class 2
Risk

K023755 is an FDA 510(k) clearance for the WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MAS.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Winner Industries (Shenzhen) Co., Ltd. (Ontario, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 214 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.

View all Winner Industries (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K023755

510(k) Number K023755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2002
Decision Date June 10, 2003
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 129d · This submission: 214d
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 528
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K023755.
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · Safety-Med Products, Inc. · Dec 2004
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
K022256 · Tucker & Associates · Apr 2004
MEGATECH SCIENTIFIC FACE MASK
K030239 · Megatech Scientific Pte, Ltd. · Jul 2003
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
K021533 · Creative Contract (M) Sdn Bhd · Mar 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
K021539 · Creative Contract (M) Sdn Bhd · Mar 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · Creative Contract (M) Sdn Bhd · Mar 2003