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510(k) Data Aggregation

    K Number
    K030484
    Device Name
    SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    2003-03-06

    (20 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 hand or finger to prevent contamination between patient and examiner.

    Device Description

    Emerald Medical, Inc. Syntheticare Powdered Vinyl Patient Examination Gloves

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a medical glove. It does not contain any information about acceptance criteria, device performance data, study designs (training or test sets), expert qualifications, ground truth establishment, or any AI/algorithm specific details.

    Therefore, I cannot provide the requested information. The document pertains to a medical device approval that predates the common use of AI in medical diagnostics and does not include any performance data in the typical sense for such devices (e.g., sensitivity, specificity for classification tasks). It's a regulatory approval based on "substantial equivalence" to a predicate device.

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