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510(k) Data Aggregation

    K Number
    K211390
    Device Name
    Nitrile Blue Powder-free Examination Glove
    Manufacturer
    Cardinal Health 200, LLC
    Date Cleared
    2021-08-28

    (115 days)

    Product Code
    LZA,LZC
    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. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

    Device Description

    Nitrile Blue Powder-Free Examination Gloves

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Blue Powder-free Examination Gloves." It is a clearance letter, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies of a device related to AI, image analysis, or similar technologies.

    The document only provides information about the chemical permeation resistance of the gloves to various chemotherapy drugs.

    Thus, I cannot fulfill your request for the following reasons:

    • No AI/ML Device: The device described (nitrile examination gloves) is a physical medical device, not a software or AI/ML-based device.
    • No Performance Study Data of the Type Requested: The document details the results of ASTM D6978, which is a chemical permeation test, not a performance study involving test sets, expert readers, ground truth, or MRMC analysis for an AI algorithm.
    • No Acceptance Criteria for AI/ML Performance: The "acceptance criteria" presented are minimum breakthrough times for chemotherapy drugs, not metrics like sensitivity, specificity, AUC, or other measures common for AI/ML diagnostic tools.

    Therefore, I cannot extract the information asked for in points 1-9 of your prompt from the provided text.

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