Cleared Traditional

Procedure mask/Surgical mask/Face mask (K220194) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 404
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