Cleared Traditional

Medical Face Mask (K214087) - FDA 510(k) Clearance

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

K214087 · Hubei Medlink Healthcare Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
71d
Days
Class 2
Risk

K214087 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 Medlink Healthcare Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on March 8, 2022 after a review of 71 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 Medlink Healthcare Co., Ltd. devices

Submission Details

510(k) Number K214087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date March 08, 2022
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K214087.
Yadu Medical Face Mask (Level 1)
K212330 · Henan Yadu Industrial Co., Ltd. · Mar 2022
DWFritz ASM2000
K213894 · Dwfritz Automation, Inc. · Mar 2022
Disposable Medical Face Mask
K213806 · Xiantao Zhibo Nonwoven Products Co., Ltd. · Mar 2022
Surgical Mask
K213358 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Mar 2022
ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G
K203376 · Medtecs (Taiwan) Corp. · Mar 2022
ROKI Surgical Mask
K214094 · Roki Co., Ltd. · Feb 2022