Cleared Traditional

Dukal Corporation AAMI Level 4 Open-Back Protective Gown

K212464 · Dukal Corporation · General Hospital

Mar 2022

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K212464 is an FDA 510(k) clearance for the Dukal Corporation AAMI Level 4 Open-Back 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 Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on March 30, 2022, 236 days after receiving the submission on August 6, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K212464 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2021
Decision Date	March 30, 2022
Days to Decision	236 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.