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510(k) Data Aggregation

    K Number
    K993847
    Device Name
    TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
    Manufacturer
    LONGBEST (XIAMEN) BALLS CO., LTD
    Date Cleared
    2000-01-18

    (67 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES

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

    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Vinyl Powdered Patient Examination Gloves

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter about "Teh Loong Vinyl, Powdered Patient Examination Gloves" (K993847) is a clearance letter for a 510(k) submission. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    This type of document does not contain the detailed information necessary to answer your request about acceptance criteria, study design, expert qualifications, or comparative effectiveness. The letter is a regulatory approval, not a scientific study report.

    Therefore, I cannot extract the information required to populate the table and answer the specific questions you've posed.

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