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    K Number
    K102119
    Device Name
    SUR-G GLOV AND MAXITEX
    Manufacturer
    TERANG NUSA SDN BHD
    Date Cleared
    2010-08-27

    (30 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUR-G GLOV AND MAXITEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgeon's gloves are sterile gloves to be worn by surqeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.

    Device Description

    Latex Surgical Gloves Powdered, Sterile.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for "Latex Surgical Gloves Powdered, Sterile." It determines substantial equivalence for a medical device but does not contain information about acceptance criteria, efficacy studies, or device performance metrics typically associated with AI/ML-driven diagnostics or complex medical devices.

    Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. The document is primarily regulatory correspondence.

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