Cleared Traditional

Medical Face Mask (K211062) - FDA 510(k) Clearance

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

K211062 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · General Hospital
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Jun 2021
Decision
60d
Days
Class 2
Risk

K211062 is an FDA 510(k) clearance for the Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on June 8, 2021 after a review of 60 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 Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. devices

Submission Details

510(k) Number K211062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2021
Decision Date June 08, 2021
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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.
Cynthia Xiang

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 K211062.
Surgical Face Mask
K210015 · Sample King Manufacturing, Ltd. · Jun 2021
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K210767 · Hunan Triplex Precision Medical Devices Co., Ltd. · Jun 2021
Disposable Surgical Mask
K202126 · Shenzhen Peninsula Medical Co., Ltd. · Jun 2021
Disposable Surgical Mask
K202580 · Qingdao Likangyuan Medical Device Co., Ltd. · Jun 2021
Disposable Surgical Mask
K210372 · Dongguan Shin YI Healthcare Products Factory · Jun 2021
Surgical Face Mask (Ear loops and Tie-on)
K210433 · Wuhan Dymex Healthcare Co., Ltd. · Jun 2021