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510(k) Data Aggregation

    K Number
    K974223
    Device Name
    NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
    Manufacturer
    DERLIN COMPANY LTD.
    Date Cleared
    1997-12-18

    (36 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 medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Nitrile Powder Free Patient Examination Gloves

    AI/ML Overview

    I am sorry, but the provided document is a 510(k) clearance letter for "Nitrile Powder Free Patient Examination Gloves" and an "Indication For Use Statement." It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device's AI component. It is a regulatory document confirming the substantial equivalence of gloves to a predicate device. Therefore, I cannot extract the requested information from this document.

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