Protective Gown AAMI Level 4

Q: What is the product code of K222128?

The FDA product code is QPC – Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, a Class II (moderate risk) device regulated under 21 CFR 878.4040.

FDA 510(k) K222128 · Kenpax International Limited

Substantially Equivalent

510(k) numberK222128

Submission

Device name: Protective Gown AAMI Level 4
Applicant: Kenpax International Limited
Hong Kong, CN
Received: July 18, 2022
Decision date: August 8, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: QPC – Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4040
Specialty: General, Plastic Surgery

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.

Other 510(k)s with product code QPC

510(k)	Device	Applicant	Decision
K262007	PRIMED AAMI Level 3 Open Back GownsQPC · Traditional	PRIMED Medical Products, Inc.	09/11/2026SE
K261115	VR® Personal Protective Level 4 Gown (VR Gowns)QPC · Traditional	PolyConversions, Inc.	08/11/2026SE
K252940	VR® Personal Protective Level 3 Gown (VR Gowns)QPC · Traditional	PolyConversions, Inc.	12/16/2025SE
K242689	AAMI Level 4 Protective; GownQPC · Traditional	Azac Group	01/13/2025SE
K233526	Medline Open-back Level 3 Protective GownQPC · Traditional	Medline Industries, LP	03/05/2024SE
K230384	PolyWear® Personal Protective Level 3 GownQPC · Traditional	PolyConversions, Inc.	08/11/2023SE
K212464	Dukal Corporation AAMI Level 4 Open-Back Protective GownQPC · Traditional	Dukal Corporation	03/30/2022SE
K203821	Donagamex Blue Performance Protective GownQPC · Traditional	Dong Nai Garment Corporation (Donagamex)	12/17/2021SE
K210405	ProTEC-USA EZDoff GownQPC · Traditional	Cadillac Products, Inc.	12/15/2021SE
K182830	Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC · Traditional	Cardinal Health200, LLC	04/26/2019SE

More from Cardinal Health200, LLC

510(k)	Device	Decision
K222151	Sterilization WrapFRG · Traditional	03/23/2023SE
K212504	Isolation Gown AAMI Level 3FYC · Traditional	11/07/2021SE
K202899	Procedure Mask, Surgical MaskFXX · Traditional	05/20/2021SE

Questions and answers

When was Protective Gown AAMI Level 4 cleared by the FDA?

Protective Gown AAMI Level 4 (K222128) received a 510(k) decision of Substantially Equivalent on August 8, 2023, 386 days after the submission was received.

What is the product code of K222128?

The FDA product code is QPC – Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection, a Class II (moderate risk) device regulated under 21 CFR 878.4040.