VR® Personal Protective Level 3 Gown (VR Gowns)— 510(k) K252940

Name: FDA 510(k) clearance K252940
Creator: U.S. Food and Drug Administration
Published: 2025-12-16

Substantially Equivalent

PolyConversions, Inc.

FDA 510(k) clearance K252940 for VR® Personal Protective Level 3 Gown (VR Gowns), Substantially Equivalent on 2025-12-16. Applicant: PolyConversions, Inc.. Device class: 2.

Clearance details

Applicant: PolyConversions, Inc.
Product code: Code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2025-09-15
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Champaign, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPC

view all

K262007 — PRIMED AAMI Level 3 Open Back Gowns2026-09-11
K261115 — VR® Personal Protective Level 4 Gown (VR Gowns)2026-08-11
K242689 — AAMI Level 4 Protective; Gown2025-01-13
K233526 — Medline Open-back Level 3 Protective Gown2024-03-05
K230384 — PolyWear® Personal Protective Level 3 Gown2023-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.