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510(k) Data Aggregation

    K Number
    K162626
    Device Name
    THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
    Manufacturer
    TOP QUALITY GLOVE SDN. BHD
    Date Cleared
    2017-03-31

    (192 days)

    Product Code
    LZA
    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

    Thermoplastic Polyethylene Examination (TPE) Glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a Thermoplastic Polyethylene Examination (TPE) Glove. It confirms that the device is substantially equivalent to a legally marketed predicate device.

    The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device. This type of submission is for a physical medical device (gloves), not a software/AI device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets based on the provided text. This information is not relevant to a 510(k) submission for examination gloves.

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