Cleared Traditional

Cardinal HealthTM Poly-Coated Open-Back Protective Gown

K182830 · Cardinal Health200, LLC · General Hospital

Apr 2019

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K182830 is an FDA 510(k) clearance for the Cardinal HealthTM Poly-Coated 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 Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on April 26, 2019, 203 days after receiving the submission on October 5, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K182830 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 2018
Decision Date	April 26, 2019
Days to Decision	203 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.