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510(k) Data Aggregation

    K Number
    K993562
    Device Name
    POWDER FREE LATEX STERILE SURGICAL GLOVES
    Manufacturer
    TG MEDICAL SDN BHD
    Date Cleared
    1999-12-29

    (69 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 surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.

    Device Description

    LATEX SURGICAL POWDERFREE GLOVES

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for powder-free latex sterile surgical gloves. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter approves the marketing of the device based on its substantial equivalence to a predicate device. Therefore, I cannot provide the requested information.

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