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510(k) Data Aggregation

    K Number
    K980215
    Device Name
    LATEX EXAMINATION GLOVES
    Manufacturer
    P.T. WANTONG INDUSTRY
    Date Cleared
    1998-03-13

    (51 days)

    Product Code
    LYY
    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

    LATEX EXAMINATION GLOVES, Powdered

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for latex examination gloves and does not include details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications related to device performance.

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