FDA 510(k) Applications for Medical Device Product Code "QPC"

FDA 510(k) Number Applicant Device Name Decision Date
K242689 AZAC Group AAMI Level 4 Protective; Gown 01/13/2025
K160337 BAM CORPORATION LIMITED Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns 07/07/2017
K210405 Cadillac Products, Inc. ProTEC-USA EZDoff Gown 12/15/2021
K182830 Cardinal Health 200, LLC Cardinal HealthTM Poly-Coated Open-Back Protective Gown 04/26/2019
K203821 Dong Nai Garment Corporation (Donagamex) Donagamex Blue Performance Protective Gown 12/17/2021
K212464 Dukal Corporation Dukal Corporation AAMI Level 4 Open-Back Protective Gown 03/30/2022
K222128 Kenpax International Limited Protective Gown AAMI Level 4 08/08/2023
K233526 Medline Industries, LP Medline Open-back Level 3 Protective Gown 03/05/2024
K230384 Polyconversions, INC PolyWear« Personal Protective Level 3 Gown 08/11/2023


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