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510(k) Data Aggregation

    K Number
    K973904
    Device Name
    POLYMER LATEX EXAMINATION GLOVES
    Manufacturer
    SRI JOHANI SDN. BHD.
    Date Cleared
    1997-12-17

    (64 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 patient and prevent contamination between examiner.

    Device Description

    Powderfree Latex Examination Gloves Polymer Coated

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for Powderfree Latex Examination Gloves. It does not contain information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML devices or complex medical equipment. The letter confirms substantial equivalence of the gloves to previously marketed devices based on the stated indications for use, but it doesn't involve testing against specific performance criteria as would be the case for a more advanced device.

    Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text does not contain any of this information. It is a regulatory clearance document for a low-risk medical device (examination gloves) that doesn't typically require extensive performance studies with AI/ML-related metrics or expert ground truth adjudication.

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