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510(k) Data Aggregation

    K Number
    K032670
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR
    Manufacturer
    KINGSWELL INTERNATIONAL INC.
    Date Cleared
    2003-11-14

    (77 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KINGSWELL INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
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    K Number
    K032668
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    Manufacturer
    KINGSWELL INTERNATIONAL INC.
    Date Cleared
    2003-10-06

    (39 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KINGSWELL INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
    Ask a Question

    Ask a specific question about this device

    K Number
    K032630
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
    Manufacturer
    KINGSWELL INTERNATIONAL INC.
    Date Cleared
    2003-10-03

    (38 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    KINGSWELL INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES
    Ask a Question

    Ask a specific question about this device

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