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510(k) Data Aggregation

    K Number
    K992219
    Device Name
    POWDERED LATEX STERILE SURGICAL GLOVES
    Manufacturer
    TG MEDICAL SDN BHD
    Date Cleared
    1999-07-30

    (29 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 GLOVE, POWDERED AND STERILE

    AI/ML Overview

    This document is a 510(k) clearance letter for Powdered Latex Sterile Surgical Gloves. It does not contain information about acceptance criteria, device performance studies, or clinical trial parameters like sample size, ground truth, or expert qualifications. The letter confirms substantial equivalence to a legally marketed predicate device but does not detail the testing used to establish that equivalence.

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