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510(k) K203821

Device
Donagamex Blue Performance Protective Gown
Applicant
Dong Nai Garment Corporation (Donagamex)
510(k) number
K203821
Product code
QPC  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-17
Date received
2020-12-29
Regulation
878.4040
Classification name
Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bui The Kich
Address
Rd. 2, Bien Hoa Industrial Zone 1 An Binh Ward Bien Hoa City VN 810000 810000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QPC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.2025-12-16
K242689AAMI Level 4 Protective; GownAzac Group2025-01-13
K233526Medline Open-back Level 3 Protective GownMedline Industries, LP2024-03-05
K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.2023-08-11
K222128Protective Gown AAMI Level 4Kenpax International Limited2023-08-08
K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation2022-03-30
K210405ProTEC-USA EZDoff GownCadillac Products, Inc.2021-12-15
K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC2019-04-26
K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited2017-07-07

Legacy Summary#

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FDA Review#

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