Cleared Traditional

K203704 - Surgical face mask

K203704 is an FDA 510(k) clearance for Surgical face mask, manufactured by Juntech(Jiaxing)Healthcare Materials Co,.Ltd. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K203704 · Juntech(Jiaxing)Healthcare Materials Co,.Ltd · General Hospital
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Jun 2021
Decision
168d
Days
Class 2
Risk

K203704 is an FDA 510(k) clearance for the Surgical face mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Juntech(Jiaxing)Healthcare Materials Co,.Ltd (Jiaxing, CN). The FDA issued a Cleared decision on June 4, 2021 after a review of 168 days - an extended review 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: 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 Juntech(Jiaxing)Healthcare Materials Co,.Ltd devices

FDA 510(k) Submission Details - K203704

510(k) Number K203704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2020
Decision Date June 04, 2021
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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

Feiying Drug & Medical Consulting Technical Service Group
Gamma Zhang

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 K203704.
Surgical Face Mask (Ear loops and Tie-on)
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Disposable Medical Mask
K210641 · Tuosheng Protective Products (Ningbo) Co., Ltd. · Jun 2021
Disposable medical mask
K203388 · Everwin Toys (Dongguan)., Ltd. · Jun 2021
Allmed Surgical Face Masks (Ear loops)
K202128 · Allmed Medical Products Co., Ltd. · Jun 2021
Surgical Face Mask
K203190 · Rfx+Care Manufactoring Co., Ltd. · Jun 2021
Disposable Medical mask
K210150 · Hubei Wanli Protective Products Co., Ltd. · Jun 2021