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510(k) Data Aggregation

    K Number
    K033877
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
    Manufacturer
    ONE TOUCH PRODUCTS CO., LTD.
    Date Cleared
    2004-01-16

    (32 days)

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

    ONE TOUCH PRODUCTS CO., LTD.

    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 EYAMINER EXAMINER.
    Device Description
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
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