Cleared Traditional

3-Ply Disposable Medical Mask (K223045) - FDA 510(k) Clearance

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

K223045 · Wealth Lead Industrial Limited · General Hospital
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Dec 2022
Decision
69d
Days
Class 2
Risk

K223045 is an FDA 510(k) clearance for the 3-Ply Disposable Medical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Wealth Lead Industrial Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 7, 2022 after a review of 69 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 Wealth Lead Industrial Limited devices

Submission Details

510(k) Number K223045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date December 07, 2022
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K223045.
Surgical Mask
K213601 · Wuhan Zonsen Medical Products Co., Ltd. · Dec 2022
PM Excellence SEQUR 100 Surgical Face Mask
K220520 · Pm Excellence, LLC · Dec 2022
Surgical Face Mask
K222651 · Xiantao Sanda Industrial Co., Ltd. · Dec 2022
Disposable Medical Face Mask
K223055 · Xiantao Zhuobo Industrial Co., Ltd. · Dec 2022
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
K223068 · Guangdong Golden Leaves Technology Development Co., Ltd. · Nov 2022
Banded Face Mask
K223003 · Hubei Medlink Healthcare Co., Ltd. · Nov 2022