Cleared Traditional

Disposable Medical Face Mask (K220487) - FDA 510(k) Clearance

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

K220487 · Hubei Mediunion Medical Products Co., Ltd. · General Hospital
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Apr 2022
Decision
63d
Days
Class 2
Risk

K220487 is an FDA 510(k) clearance for the Disposable Medical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Hubei Mediunion Medical Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on April 26, 2022 after a review of 63 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 Mediunion Medical Products Co., Ltd. devices

Submission Details

510(k) Number K220487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date April 26, 2022
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K220487.
Procedure mask/Surgical mask/Face mask
K220194 · Winner Medical Co., Ltd. · May 2022
Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
K220749 · Unimax Medical Products Co., Ltd. · May 2022
Procedure Mask, Surgical Mask
K213001 · A Plus International, Inc. · May 2022
Disposable Surgical Face Mask (M01, M02)
K220512 · Fomed Industries, Inc. · Apr 2022
Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
K210860 · Gri-Alleset, Inc. · Apr 2022
Dong Hai Xiang Surgical Mask
K212203 · Taizhou Donghaixiang Protective Equipment Co., Ltd. · Apr 2022