Cleared Traditional

Surgical Face Mask (K212368) - FDA 510(k) Clearance

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

K212368 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
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Oct 2021
Decision
86d
Days
Class 2
Risk

K212368 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on October 24, 2021 after a review of 86 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 Anhui Tiankang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K212368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2021
Decision Date October 24, 2021
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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

Shanghai Sungo Management Consulting Company Limited.
Eva Li

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 K212368.
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
Surgical 3D Mask
K203565 · Inno Lifecare · Oct 2021
Medical Protective Masks
K212205 · Qinhuangdao Taizhi Medical Technology Co., Ltd. · Oct 2021
Disposable Surgical Mask (Model: YYKZ-01)
K210845 · Jiaxing Amazing Travel-Ware Co., Ltd. · Oct 2021