PolyWear® Personal Protective Level 3 Gown— 510(k) K230384

Name: FDA 510(k) clearance K230384
Creator: U.S. Food and Drug Administration
Published: 2023-08-11

Substantially Equivalent

PolyConversions, Inc.

FDA 510(k) clearance K230384 for PolyWear® Personal Protective Level 3 Gown, Substantially Equivalent on 2023-08-11. 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: 2023-02-14
Decision date: 2023-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Champaign, IL, US

Download summary PDF View on FDA.gov ↗

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