Cleared Traditional

Protective Face Mask for Medical Use (K201537) - FDA 510(k) Clearance

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

K201537 · Shandong Shengquan New Material Co., Ltd. · General Hospital
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Sep 2020
Decision
88d
Days
Class 2
Risk

K201537 is an FDA 510(k) clearance for the Protective Face Mask for Medical Use. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Shandong Shengquan New Material Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on September 4, 2020 after a review of 88 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 Shandong Shengquan New Material Co., Ltd. devices

Submission Details

510(k) Number K201537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date September 04, 2020
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 Landlink Medical Information Technology Co., Ltd.
Shelley 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 K201537.
Disposable Medical Face Mask
K201470 · Jkh USA, LLC · Sep 2020
Surgical Mask-Model Number CW01
K202354 · Hunan Heng Chang Pharmaceutical Co., Ltd. · Sep 2020
Plain Surgical Mask
K201517 · Aok Tooling Limited · Sep 2020
Single-use Surgical Mask
K200923 · Byd Precision Manufacturer Co., Ltd. · Aug 2020
Motex Anti-Fog Surgical Face Mask
K201549 · Modern Healthcare Corp. · Aug 2020
Asept Surgical Face Mask
K201137 · Pfm Medical, Inc. · Aug 2020