Cleared Traditional

PolyWear? Personal Protective Level 3 Gown

K230384 · PolyConversions, Inc. · General Hospital

Aug 2023

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K230384 is an FDA 510(k) clearance for the PolyWear? Personal Protective Level 3 Gown, a Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (Class II — Special Controls, product code QPC), submitted by PolyConversions, Inc. (Champaign, US). The FDA issued a Cleared decision on August 11, 2023, 178 days after receiving the submission on February 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K230384 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2023
Decision Date	August 11, 2023
Days to Decision	178 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.