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510(k) Data Aggregation

    K Number
    K250306
    Device Name
    Chex-All Sterilization Pouches and Tubes
    Manufacturer
    Propper Manufacturing Co, Inc.
    Date Cleared
    2025-10-31

    (270 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250325
    Device Name
    BD Alaris Pump Infusion Set
    Manufacturer
    CareFusion (BD)
    Date Cleared
    2025-10-30

    (267 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252467
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Viet Phu Trade and Import Export Co., Ltd
    Date Cleared
    2025-10-27

    (82 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250345
    Device Name
    Medline Bag Decanter
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2025-10-24

    (260 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250861
    Device Name
    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
    Manufacturer
    Hartalega NGC Sdn. Bhd.
    Date Cleared
    2025-10-23

    (216 days)

    Product Code
    LZA,LZC,OPJ,QDO
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251663
    Device Name
    Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
    Manufacturer
    Datex-Ohmeda. Inc.
    Date Cleared
    2025-10-22

    (145 days)

    Product Code
    FMZ
    Regulation Number
    880.5400
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253033
    Device Name
    Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
    Manufacturer
    Simplivia Healthcare Ltd.
    Date Cleared
    2025-10-21

    (29 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252075
    Device Name
    Program insite® Powder-Free, Disposable Nitrile Exam Gloves
    Manufacturer
    Program insite LLC
    Date Cleared
    2025-10-17

    (107 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252631
    Device Name
    Profoject™ Disposable Needle
    Manufacturer
    CMT Health PTE. Ltd.
    Date Cleared
    2025-10-16

    (57 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250510
    Device Name
    Sure-Fine Insulin Syringes
    Manufacturer
    SHINA MED CORPORATION
    Date Cleared
    2025-10-15

    (236 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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