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510(k) Data Aggregation

    K Number
    K971183
    Device Name
    GOLD FINGERS
    Manufacturer
    ALLIANCE RUBBER PRODUCTS SDN. BHD.
    Date Cleared
    1997-08-08

    (130 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    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 medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for a device, a study proving the device meets said criteria, or any details related to AI/algorithm performance. The document is an FDA 510(k) clearance letter for "Gold Finger Latex Patient Examination Gloves, Powder-Free with water extractable protein labeling claim."

    It primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

    Therefore, I cannot provide the requested information based on the input text.

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