Cleared Traditional

Medline Open-back Level 3 Protective Gown

K233526 · Medline Industries, LP · General Hospital

Mar 2024

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K233526 is an FDA 510(k) clearance for the Medline Open-back Level 3 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 Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on March 5, 2024, 125 days after receiving the submission on November 1, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K233526 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2023
Decision Date	March 05, 2024
Days to Decision	125 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.