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510(k) Data Aggregation

    K Number
    K984094
    Device Name
    VINYL EXAMINATION GLOVES, PREPOWDERED USP
    Manufacturer
    TRANS ANCIENT PRODUCTS CO., LTD.
    Date Cleared
    1999-01-14

    (59 days)

    Product Code
    LYZ,IYZ
    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

    Patient Examination Gloves

    A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Vinyl Examination Gloves, Prepowdered, USP

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study. The document is a clearance letter from the FDA for a 510(k) submission for "Vinyl Examination Gloves, Prepowdered USP," indicating their substantial equivalence to a legally marketed predicate device. It confirms the device's classification and allows its marketing.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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