Cleared Traditional

Medical Face Mask (K211363) - FDA 510(k) Clearance

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

K211363 · Hubei Kangning Protective Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
82d
Days
Class 2
Risk

K211363 is an FDA 510(k) clearance for the Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Hubei Kangning Protective Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on July 24, 2021 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hubei Kangning Protective Products Co., Ltd. devices

Submission Details

510(k) Number K211363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date July 24, 2021
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K211363.
Surgical Mask
K211497 · Honeywell Safety Products · Jul 2021
TAIJI Professional Series Level 3 Surgical Face Mask
K211861 · Taiji Medical Supplies, Inc. · Jul 2021
MASC Surgical Mask
K211984 · Mid-America Safety Corp. · Jul 2021
Altor Safety 3-Ply Surgical Mask (Model:62222)
K211249 · Altor Safety, LLC · Jul 2021
Single-use medical face mask
K210391 · Zhuhai Herald Datanetics Limited. · Jul 2021
Surgical face mask (Model: Flat Ear Loop/CN102)
K203534 · Crown Name Disposable Hygiene Products Fty., Ltd. · Jul 2021