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510(k) Data Aggregation

    K Number
    K993386
    Device Name
    LATEX EXAMINATION POWDERED GLOVES
    Manufacturer
    GREAT GLOVE SDN BHD
    Date Cleared
    1999-12-20

    (73 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LATEX EXAMINATION POWDERED GLOVES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

    Device Description

    Latex Examination Powdered Gloves

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Powdered Gloves," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

    The document discusses the regulatory classification, general controls, and market authorization for the gloves. It also includes an "Indications for Use Statement" for the product. However, it does not contain any details about performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

    Therefore, I cannot provide the requested information in the specified format.

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