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510(k) Data Aggregation

    K Number
    K163035
    Device Name
    DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
    Manufacturer
    Elm Tree Medical, Inc.
    Date Cleared
    2017-07-07

    (249 days)

    Product Code
    LZA,FTY
    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. Additionally, this device has the added component of a measuring tape to aid clinicians in the measurement of cervical dilation.

    Device Description

    DilaCheck™ Nitrile Powder Free Examination Glove, (Sterile)

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a patient examination glove, specifically the "DilaCheck™ Nitrile Powder Free Examination Glove, (Sterile)".

    This document does NOT contain information about a medical device that utilizes artificial intelligence (AI) or machine learning (ML), nor does it describe a study involving a test set, ground truth experts, or statistical performance metrics like sensitivity, specificity, or AUC.

    The document grants substantial equivalence to a predicate device for a physical product (a glove with a measuring tape component), not a software or AI-driven diagnostic or prognostic tool. Therefore, it does not include the type of information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/ML device.

    To directly answer your prompt based on the provided document, I must state that the requested information is not present. The document pertains to a Class I medical device (gloves) and focuses on regulatory clearance for manufacturing and marketing, not on the performance evaluation of a complex diagnostic or AI system.

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