Cleared Traditional

GD Disposable Medical Face Mask (K201718) - FDA 510(k) Clearance

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

K201718 · Jiangsu Guangda Medical Material Group Co., Ltd. · General Hospital
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Apr 2021
Decision
296d
Days
Class 2
Risk

K201718 is an FDA 510(k) clearance for the GD Disposable Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jiangsu Guangda Medical Material Group Co., Ltd. (Libao Town, CN). The FDA issued a Cleared decision on April 15, 2021 after a review of 296 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 Jiangsu Guangda Medical Material Group Co., Ltd. devices

Submission Details

510(k) Number K201718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2020
Decision Date April 15, 2021
Days to Decision 296 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
167d slower than avg
Panel avg: 129d · This submission: 296d
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

Rogers Consulting
W. Victoria Rogers

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201718.
Medical Surgical Mask
K210030 · Tianjin Aoshang Outdoor Equipment Co., Ltd. · Apr 2021
Disposable Medical Face Mask
K203646 · Guangzhou Mei YI Kang Medical Technology Co., Ltd. · Apr 2021
Disposable medical surgical mask
K202759 · Chongqing Coe Display Technology Co., Ltd. · Apr 2021
DEFEND Ear-loop Face Masks
K201127 · Young Dental Manufacturing Co. 1, LLC · Apr 2021
Medical Surgical Mask (Non-sterile)
K202761 · Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. · Apr 2021
Surgical Mask
K203012 · Customfab, Inc. · Apr 2021