Cleared Traditional

K212471 - Medical Face Mask

K212471 is an FDA 510(k) clearance for Medical Face Mask, manufactured by Haian Medigauze Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K212471 · Haian Medigauze Co., Ltd. · General Hospital
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Nov 2021
Decision
90d
Days
Class 2
Risk

K212471 is an FDA 510(k) clearance for the Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Haian Medigauze Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on November 4, 2021 after a review of 90 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 Haian Medigauze Co., Ltd. devices

FDA 510(k) Submission Details - K212471

510(k) Number K212471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2021
Decision Date November 04, 2021
Days to Decision 90 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 faster than avg
Panel avg: 129d · This submission: 90d
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 Peers - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K212471.
Surgical Face Mask
K212526 · Suzhou Janee Medical Technology Co., Ltd. · Nov 2021
Disposable Medical Face Mask
K202676 · Zhejiang Senhong Medical&Instrument Co., Ltd. · Nov 2021
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
K212460 · Guangzhou Zhengkang Medical Equipment Co.,Ltd · Nov 2021
Disposable Medical Mask
K210222 · Guangdong Lide Medical Technology Co., Ltd. · Nov 2021
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
K212293 · Jiangmen Ningrui Medical Supplies Co., Ltd. · Oct 2021
Disposable Medical Surgical Mask
K210348 · Weihai Dishang Medical Technology Co., Ltd. · Oct 2021