Cleared Traditional

Surgical Masks (K203524) - FDA 510(k) Clearance

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

K203524 · Bain Medical Equipment (Guangzhou) Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
86d
Days
Class 2
Risk

K203524 is an FDA 510(k) clearance for the Surgical Masks. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 25, 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 Bain Medical Equipment (Guangzhou) Co., Ltd. devices

Submission Details

510(k) Number K203524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2020
Decision Date February 25, 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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 K203524.
Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K201852 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2021
IFM Surgical Mask Model SM3
K202214 · Fssc, LLC · Mar 2021
Disposable Surgical Mask/Fluid Resistant Procedure Mask
K202240 · Lhm Medical Technology (Hong Kong) Limited · Feb 2021
Phyziofit Medical Surgical Mask
K201868 · Wellpower Sporting Goods Co., Ltd. · Feb 2021
iMask Disposable Surgical Face Mask
K201182 · Pac-Dent, Inc. · Feb 2021
Surgical Face Mask (non-sterile)
K203426 · Nantong Taiweishi Medical Technology Co., Ltd. · Feb 2021