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510(k) Data Aggregation

    K Number
    K052030
    Device Name
    SURGEON'S GLOVE, POWDER FREE
    Manufacturer
    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
    Date Cleared
    2005-09-13

    (48 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

    Device Description

    The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.

    AI/ML Overview

    I am sorry, but the PDF provided does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA regarding "Surgeon's Glove Powder Free" and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/device performance study.

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