Cleared Traditional

Standard Procedure Mask, Standard Surgical Mask (K202605) - FDA 510(k) Clearance

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

K202605 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · General Hospital
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Feb 2021
Decision
155d
Days
Class 2
Risk

K202605 is an FDA 510(k) clearance for the Standard Procedure Mask, Standard Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (Siyang, CN). The FDA issued a Cleared decision on February 10, 2021 after a review of 155 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 Medplus Non-Woven Manufacturer Co., Ltd. devices

Submission Details

510(k) Number K202605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2020
Decision Date February 10, 2021
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K202605.
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
K201732 · Dukal Corporation · Feb 2021
Surgical Face Mask
K201545 · Amphastar Nanjing Pharmaceuticals, Inc. · Feb 2021
Disposable Surgical Mask
K202341 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Feb 2021
nPro Surgical Mask
K203265 · Np Medical, Inc. · Feb 2021
Dukal Corporation Level 2 Surgical Mask with Ear Loops
K201421 · Dukal Corporation · Feb 2021
Freudenberg Surgical Mask
K210063 · Freudenberg Performance Materials LP · Feb 2021