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510(k) Data Aggregation

    K Number
    K163035
    Device Name
    DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
    Manufacturer
    Elm Tree Medical, Inc.
    Date Cleared
    2017-07-07

    (249 days)

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

    Elm Tree Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Additionally, this device has the added component of a measuring tape to aid clinicians in the measurement of cervical dilation.
    Device Description
    DilaCheck™ Nitrile Powder Free Examination Glove, (Sterile)
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