Cleared Traditional

K222128 - Protective Gown AAMI Level 4

K222128 is an FDA 510(k) clearance for Protective Gown AAMI Level 4, manufactured by Kenpax International Limited. The device is a Class 2 General Hospital device with product code QPC cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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

FDA 510(k) Submission Details - K222128

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
257d slower than avg
Panel avg: 129d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPC Device Classification - Class 2, Special Controls

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 8
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K222128.
AAMI Level 4 Protective
K242689 · Azac Group · Jan 2025
Medline Open-back Level 3 Protective Gown
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
ProTEC-USA EZDoff Gown
K210405 · Cadillac Products, Inc. · Dec 2021