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

FDA 510(k) Number Applicant Device Name Decision Date
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
K230384 Polyconversions, INC PolyWear« Personal Protective Level 3 Gown 08/11/2023


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