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510(k) Data Aggregation

    K Number
    K982872
    Device Name
    TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    TG MEDICAL SDN BHD
    Date Cleared
    1998-10-15

    (62 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

    Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.

    Device Description

    LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less)

    AI/ML Overview

    I am sorry, but the provided text does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for "TG Medical Powder-Free Latex Examination Glove," which primarily addresses regulatory equivalence to a predicate device. It explicitly states that "this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations."

    Therefore, I cannot fulfill your request based on the provided input.

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