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510(k) Data Aggregation

    K Number
    K073447
    Device Name
    SURGI GLOVES
    Manufacturer
    METACURE SURGICAL GLOVES SDN BHD
    Date Cleared
    2008-04-24

    (139 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

    A powder free nitrile surgical glove is a disposable device intended to be worn on the hands by operating room personnel to provide a barrier against potentially infectious materials and other contaminants.

    Device Description

    Sterile Powder Free Nitrile Surgical Gloves

    AI/ML Overview

    I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The provided document is a 510(k) clearance letter from the FDA for Sterile Powder Free Nitrile Surgical Gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework.

    The document does not contain any information about:

    • Specific acceptance criteria for device performance (e.g., tensile strength, puncture resistance, barrier integrity metrics).
    • Any studies conducted to demonstrate the device meets acceptance criteria.
    • Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
    • Information regarding multi-reader multi-case studies or standalone algorithm performance.

    Therefore, I cannot provide the requested information.

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