Cleared Traditional

K242689 - AAMI Level 4 Protective (FDA 510(k) Clearance)

Also includes:
Gown

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

K242689 · Azac Group · General Hospital
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Jan 2025
Decision
129d
Days
Class 2
Risk

K242689 is an FDA 510(k) clearance for the AAMI Level 4 Protective. Classified as Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC), Class II - Special Controls.

Submitted by Azac Group (City Of Industry, US). The FDA issued a Cleared decision on January 13, 2025 after a review of 129 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Azac Group devices

Submission Details

510(k) Number K242689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2024
Decision Date January 13, 2025
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 128d · This submission: 129d
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 Consultant

Qpm Consulting
Robert Seiple

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 - 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 K242689.
VR® Personal Protective Level 3 Gown (VR Gowns)
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Medline Open-back Level 3 Protective Gown
K233526 · Medline Industries, LP · Mar 2024
PolyWear® Personal Protective Level 3 Gown
K230384 · PolyConversions, Inc. · Aug 2023
Protective Gown AAMI Level 4
K222128 · Kenpax International Limited · 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