Cleared Traditional

Medical Face mask (K202061) - FDA 510(k) Clearance

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

K202061 · Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · General Hospital
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Dec 2020
Decision
149d
Days
Class 2
Risk

K202061 is an FDA 510(k) clearance for the Medical Face mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 23, 2020 after a review of 149 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 Jiangsu Province Jianerkang Medical Dressing Co., Ltd. devices

Submission Details

510(k) Number K202061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date December 23, 2020
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K202061.
Disposable Medical Face Masks
K202719 · Jiangxi Sanxin Medtec Co., Ltd. · Jan 2021
Nordiwell Medical Face Mask
K202615 · Changzhou Combat Protective Equipment Co., Ltd. · Dec 2020
JianYu Surgical Mask
K201754 · Jiangsu Jianyu Health Medical Co., Ltd. · Dec 2020
Disposable Medical Surgical Face Masks
K202211 · Guangdong Kaidi Garments Co.,Ltd · Dec 2020
Medical Surgical Mask
K202029 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Dec 2020
Medical Face Mask
K201629 · Shandong Shengquan New Material Co., Ltd. · Dec 2020