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510(k) Data Aggregation

    K Number
    K043159
    Device Name
    POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Manufacturer
    SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD.
    Date Cleared
    2004-12-20

    (35 days)

    Product Code
    LYZ
    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 examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Powder Free Clear Synthetic Vinyl Examination Gloves

    AI/ML Overview

    This document is a 510(k) clearance letter for Powder Free Clear Synthetic Vinyl Examination Gloves, not a study report for an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from the provided text.

    The document discusses the substantial equivalence of the gloves to legally marketed predicate devices and outlines general regulatory requirements for medical devices. It does not contain any information about:

    • Acceptance criteria for an AI/ML algorithm.
    • Performance metrics of an AI/ML device.
    • Sample sizes for test or training sets for AI/ML.
    • Data provenance or ground truth establishment for AI/ML.
    • Expert involvement in AI/ML performance evaluation.
    • MRMC studies for AI/ML.
    • Standalone performance or human-in-the-loop performance of AI/ML.
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