Cleared Traditional

K223232 - Procedure mask/Surgical mask/Face mask

K223232 is an FDA 510(k) clearance for Procedure mask/Surgical mask/Face mask, manufactured by Winner Medical Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K223232 · Winner Medical Co., Ltd. · General Hospital
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Mar 2023
Decision
138d
Days
Class 2
Risk

K223232 is an FDA 510(k) clearance for the Procedure mask/Surgical mask/Face mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 6, 2023 after a review of 138 days - within the typical 510(k) review window.

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 Medical Co., Ltd. devices

FDA 510(k) Submission Details - K223232

510(k) Number K223232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2022
Decision Date March 06, 2023
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K223232.
Medline Surgical Face Mask and Medline Procedural Face Mask
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K230383 · Alg Health, LLC · Mar 2023
Disposable 4 Layers Surgical Face Mask
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Medical Protective Masks
K223686 · Qinhuangdao Taizhi Medical Technology Co., Ltd. · Feb 2023