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510(k) Data Aggregation

    K Number
    K973815
    Device Name
    HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-11-21

    (45 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

    Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Thick & Long Cuff Powdered Latex Examination Gloves (Blue Colour)". It confirms that the device is substantially equivalent to a legally marketed predicate device.

    This document does not contain information about acceptance criteria or a study proving device performance against acceptance criteria for an AI-powered medical device.

    Instead, it's a regulatory approval document for a physical medical device (gloves), indicating that it meets the requirements for a Class I device and can be marketed based on substantial equivalence.

    Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI device. The document is about a different type of medical product and regulatory process.

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