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510(k) Data Aggregation

    K Number
    K993865
    Device Name
    GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    SUPERMAX SDN BHD
    Date Cleared
    2000-01-20

    (66 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 powdered patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

    Device Description

    GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "Green Peppermint Flavored Powdered Latex Examination Gloves." This letter primarily addresses regulatory approval and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The information provided (e.g., FDA logo, communication regarding a 510(k) notification, product name, indications for use) is typical of a regulatory clearance for a medical device that is a physical product (gloves in this case), not a software or AI/ML device.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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