Cleared Traditional

KNH Surgical Face Mask (K203528) - FDA 510(k) Clearance

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

K203528 · Knh Surgical Face Mask · General Hospital
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Nov 2022
Decision
714d
Days
Class 2
Risk

K203528 is an FDA 510(k) clearance for the KNH Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Knh Surgical Face Mask (Tainan, TW). The FDA issued a Cleared decision on November 16, 2022 after a review of 714 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Knh Surgical Face Mask devices

Submission Details

510(k) Number K203528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2020
Decision Date November 16, 2022
Days to Decision 714 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
585d slower than avg
Panel avg: 129d · This submission: 714d
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

Knh Enterprise Co., Ltd.
Brian Wu

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 K203528.
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Banded Face Mask
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Disposable surgical face mask
K220302 · Shandong Aida Medical Products Co., Ltd. · Nov 2022
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