Cleared Traditional

Medical Surgical Mask (K222204) - FDA 510(k) Clearance

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

K222204 · Guangzhou Zhengkang Medical Equipment Co.,Ltd · General Hospital
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Sep 2022
Decision
60d
Days
Class 2
Risk

K222204 is an FDA 510(k) clearance for the Medical Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Guangzhou Zhengkang Medical Equipment Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on September 23, 2022 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangzhou Zhengkang Medical Equipment Co.,Ltd devices

Submission Details

510(k) Number K222204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date September 23, 2022
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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

Feiying Drug & Medical Consulting Technical Service Group
Riley Chen

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 K222204.
Disposable Surgical Face Mask
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K222335 · Luoyang Sunmed Devices Co., Ltd. · Oct 2022
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
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Surgical Face Mask (Non-sterile)
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AllureTM Surgical Mask
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Surgical Face Masks (Ear Loops And Tie-On)
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