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510(k) Data Aggregation

    K Number
    K220428
    Device Name
    Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
    Manufacturer
    One Glove Industrial SDN BHD
    Date Cleared
    2022-05-10

    (84 days)

    Product Code
    LZA
    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 Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    BLACK NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON-STERILE

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the clearance of a medical device (Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile). It does not contain information about the acceptance criteria and study proving device performance as outlined in your request.

    Therefore, I cannot extract the requested details such as:

    1. Table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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