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510(k) Data Aggregation

    K Number
    K112222
    Device Name
    ALCATRON AND / OR MULTIPLE BRAND
    Manufacturer
    ALCATRON GLOVES FACTORY
    Date Cleared
    2011-10-27

    (86 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 Synthetic Vinyl Examination Gloves, powder free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Synthetic Vinyl Examination Gloves, Powder-Free

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification approval letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device that would typically involve such metrics (like an AI/ML powered device).

    The information in the document pertains to regulatory approval for a physical medical device (gloves) and confirms its substantial equivalence to previously marketed predicate devices. It discusses general controls, regulations, and contact information, but not the kind of performance study details you are asking for.

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