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510(k) Data Aggregation

    K Number
    K990690
    Device Name
    POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
    Manufacturer
    TOP GLOVE SDN. BHD.
    Date Cleared
    1999-05-20

    (78 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 :

    POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES

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

    The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.

    Device Description

    Polymer Coated Powder-Free Latex Examination Gloves

    AI/ML Overview

    The provided FDA document is a 510(k) clearance letter for "Polymer Coated Powder-Free Latex Examination Gloves" (K990690). This document is an approval for a medical device and not a study report for a diagnostic AI device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and study details for an AI-powered device.

    Specifically, the document:

    1. Does not describe any AI device. It's for a physical product (gloves).
    2. Does not present acceptance criteria in the context of an algorithm's performance (e.g., sensitivity, specificity).
    3. Does not include any study data relating to algorithm performance, sample sizes, ground truth, or expert review.
    4. Does not mention multi-reader multi-case studies or standalone algorithm performance.

    Therefore, I cannot extract the requested information from the provided text.

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