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510(k) Data Aggregation

    K Number
    K063776
    Device Name
    ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
    Manufacturer
    BRIGHT ELEMENT SDN BHD
    Date Cleared
    2007-03-02

    (71 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 latex Powdered Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    LATEX POWDERED EXAMINATION GLOVES

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Latex Powdered Examination Gloves." It does not contain information about acceptance criteria or a study proving that a device meets those criteria. This type of document is for a medical device that does not require clinical studies for market clearance.

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