Cleared Traditional

AAMI Level 4 Protective; Gown

K242689 · Azac Group · General Hospital

Jan 2025

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K242689 is an FDA 510(k) clearance for the AAMI Level 4 Protective; Gown, a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II — Special Controls, product code QPC), submitted by Azac Group (City Of Industry, US). The FDA issued a Cleared decision on January 13, 2025, 129 days after receiving the submission on September 6, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K242689 FDA.gov
FDA Decision	Cleared 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

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.