Cleared Traditional

K211956 - 039 Surgical Face Mask

K211956 is an FDA 510(k) clearance for 039 Surgical Face Mask, manufactured by Aok Tooling Limited. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K211956 · Aok Tooling Limited · General Hospital
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Nov 2021
Decision
152d
Days
Class 2
Risk

K211956 is an FDA 510(k) clearance for the 039 Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Aok Tooling Limited (Shenzhen, CN). The FDA issued a Cleared decision on November 23, 2021 after a review of 152 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 Aok Tooling Limited devices

FDA 510(k) Submission Details - K211956

510(k) Number K211956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2021
Decision Date November 23, 2021
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

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

Aok Tooling Limited % Promedic, LLC
Paul Dryden

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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211956.
Disposable Surgical Face Mask
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Impertech Surgical Face Mask
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Savvy Mask - Level 3 Surgical Face Mask
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Disposable Surgical Mask
K210042 · Suzhou Letian Protective Products Co., Ltd. · Nov 2021