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510(k) Data Aggregation

    K Number
    K050455
    Device Name
    SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
    Manufacturer
    ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD
    Date Cleared
    2005-03-29

    (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 purposes that is worn on the examiner's hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)

    Device Description

    Patient Vinyl Examination Gloves, Powdered

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device described as "Patient Vinyl Examination Gloves, Powdered." This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device testing. It is a regulatory clearance document for a traditional medical device (gloves), indicating that it has been found substantially equivalent to a predicate device.

    Therefore, I cannot provide the requested information from this document. The questions about acceptance criteria, sample size, ground truth, expert qualifications, and AI study details are not applicable to the content of this regulatory letter.

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