VR® Personal Protective Level 4 Gown (VR Gowns)— 510(k) K261115

Name: FDA 510(k) clearance K261115
Creator: U.S. Food and Drug Administration
Published: 2026-08-11

Substantially Equivalent

PolyConversions, Inc.

FDA 510(k) clearance K261115 for VR® Personal Protective Level 4 Gown (VR Gowns), Substantially Equivalent on 2026-08-11. Applicant: PolyConversions, Inc.. Device class: 2.

Summary

PolyConversions' VR Personal Protective Level 4 Gown (VR Gowns) is filed under product code QPC, non-sterile, non-isolation gowns intended to provide moderate or high barrier protection.

Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.

PolyConversions filed from Champaign, Illinois. The decision came 130 calendar days after receipt (April 3 to August 11, 2026), and it was substantially equivalent.

Clearance details

Applicant: PolyConversions, Inc.
Product code: Product code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2026-04-03
Decision date: 2026-08-11
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
K252940 — VR® Personal Protective Level 3 Gown (VR Gowns)2025-12-16
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.