Cleared Traditional

K222128 - Protective Gown AAMI Level 4 (FDA 510(k) Clearance)

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

K222128 · Kenpax International Limited · General Hospital
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Aug 2023
Decision
386d
Days
Class 2
Risk

K222128 is an FDA 510(k) clearance for the Protective Gown AAMI Level 4. Classified as Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC), Class II - Special Controls.

Submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 8, 2023 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kenpax International Limited devices

Submission Details

510(k) Number K222128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date August 08, 2023
Days to Decision 386 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 128d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded.
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 - QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

All 9
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K222128.
VR® Personal Protective Level 3 Gown (VR Gowns)
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AAMI Level 4 Protective
K242689 · Azac Group · Jan 2025
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K233526 · Medline Industries, LP · Mar 2024
PolyWear® Personal Protective Level 3 Gown
K230384 · PolyConversions, Inc. · Aug 2023
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · Dukal Corporation · Mar 2022
Donagamex Blue Performance Protective Gown
K203821 · Dong Nai Garment Corporation (Donagamex) · Dec 2021