Cleared Traditional

Surgical Face Mask (K221352) - FDA 510(k) Clearance

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

K221352 · Wuhan Huashida Protective Products Co., Ltd. · General Hospital
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Mar 2023
Decision
307d
Days
Class 2
Risk

K221352 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Wuhan Huashida Protective Products Co., Ltd. (Wuhan,, CN). The FDA issued a Cleared decision on March 13, 2023 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Wuhan Huashida Protective Products Co., Ltd. devices

Submission Details

510(k) Number K221352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2022
Decision Date March 13, 2023
Days to Decision 307 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
178d slower than avg
Panel avg: 129d · This submission: 307d
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 Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K221352.
Disposable Medical Mask
K222545 · Guangzhou Fuzelong Hygiene Material Co., Ltd. · May 2023
Disposable Surgical Face Mask
K223823 · Efofex, Inc. · Mar 2023
Medline Surgical Face Mask and Medline Procedural Face Mask
K223236 · Medline Industries, LP · Mar 2023
PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
K221209 · Padm Medical, Inc. · Mar 2023
Procedure mask/Surgical mask/Face mask
K223232 · Winner Medical Co., Ltd. · Mar 2023
Savvy Surgical Mask - Level 3
K230383 · Alg Health, LLC · Mar 2023