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510(k) Data Aggregation

    K Number
    K980940
    Device Name
    SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-04-03

    (22 days)

    Product Code
    LYY
    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
    Intended Use

    A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Safety Powderfree Blue Latex Examination Gloves

    AI/ML Overview

    The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Safety Powderfree Blue Latex Examination Gloves" and does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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