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Panels › General, Plastic Surgery › Product code QPC · Class 2

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Regulation 878.4040

3510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QPC

Company510(k)sRecalls
PolyConversions, Inc.30
Azac Group10
Bam Corporation Limited10
Cadillac Products, Inc.10
Cardinal Health200, LLC10
Dong Nai Garment Corporation (Donagamex)10
Dukal Corporation10
Kenpax International Limited10
Medline Industries, LP10
PRIMED Medical Products, Inc.10
Decided510(k)Device and applicantCode
Sep 11, 2026K262007PRIMED AAMI Level 3 Open Back Gowns
PRIMED Medical Products, Inc., CA
QPC
Aug 11, 2026K261115VR® Personal Protective Level 4 Gown (VR Gowns)
PolyConversions, Inc.
QPC
Dec 16, 2025K252940VR® Personal Protective Level 3 Gown (VR Gowns)
PolyConversions, Inc.
QPC
Jan 13, 2025K242689AAMI Level 4 Protective; Gown
Azac Group
QPC
Mar 5, 2024K233526Medline Open-back Level 3 Protective Gown
Medline Industries, LP
QPC
Aug 11, 2023K230384PolyWear® Personal Protective Level 3 Gown
PolyConversions, Inc.
QPC
Aug 8, 2023K222128Protective Gown AAMI Level 4
Kenpax International Limited, CN
QPC
Mar 30, 2022K212464Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Dukal Corporation
QPC
Dec 17, 2021K203821Donagamex Blue Performance Protective Gown
Dong Nai Garment Corporation (Donagamex), VN
QPC
Dec 15, 2021K210405ProTEC-USA EZDoff Gown
Cadillac Products, Inc.
QPC
Apr 26, 2019K182830Cardinal HealthTM Poly-Coated Open-Back Protective Gown
Cardinal Health200, LLC
QPC
Jul 7, 2017K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Bam Corporation Limited, CN
QPC

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