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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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