Cleared Traditional

K220194 - Procedure mask/Surgical mask/Face mask

K220194 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 113-day FDA review.

K220194 · Winner Medical Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2022
Decision
113d
Days
Class 2
Risk

K220194 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 May 17, 2022 after a review of 113 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 - K220194

510(k) Number K220194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2022
Decision Date May 17, 2022
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K220194.
Disposable surgical mask
K220532 · Xiamen Blue Star Enterprise Co., Ltd. · May 2022
Medical Surgical Mask (Planar type)
K220824 · Hunan Chopard Medical Devices Co., Ltd. · May 2022
Procedure Mask with Ear Loops and Surgical Mask with Ties
K221134 · Safesource Direct, LLC · May 2022
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
K220749 · Unimax Medical Products Co., Ltd. · May 2022
Procedure Mask, Surgical Mask
K213001 · A Plus International, Inc. · May 2022
Disposable Medical Face Mask
K220487 · Hubei Mediunion Medical Products Co., Ltd. · Apr 2022