Protective Gown AAMI Level 4— 510(k) K222128

Name: FDA 510(k) clearance K222128
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Substantially Equivalent

Kenpax International Limited

FDA 510(k) clearance K222128 for Protective Gown AAMI Level 4, Substantially Equivalent on 2023-08-08. Applicant: Kenpax International Limited. Device class: 2.

Clearance details

Applicant: Kenpax International Limited
Product code: Code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2022-07-18
Decision date: 2023-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPC

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K262007 — PRIMED AAMI Level 3 Open Back Gowns2026-09-11
K261115 — VR® Personal Protective Level 4 Gown (VR Gowns)2026-08-11
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

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K222151 — Sterilization Wrap2023-03-23
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K202899 — Procedure Mask, Surgical Mask2021-05-20

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