Cleared Traditional

VR? Personal Protective Level 3 Gown (VR Gowns)

K252940 · PolyConversions, Inc. · General Hospital

Dec 2025

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K252940 is an FDA 510(k) clearance for the VR? Personal Protective Level 3 Gown (VR Gowns), 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 December 16, 2025, 92 days after receiving the submission on September 15, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K252940 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2025
Decision Date	December 16, 2025
Days to Decision	92 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.