Cleared Traditional

Protective Gown AAMI Level 4

K222128 · Kenpax International Limited · General Hospital

Aug 2023

Decision

386d

Days

Class 2

Risk

About This 510(k) Submission

K222128 is an FDA 510(k) clearance for the Protective Gown AAMI Level 4, a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II — Special Controls, product code QPC), submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 8, 2023, 386 days after receiving the submission on July 18, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K222128 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QPC — Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class	Class II — 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.