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510(k) Data Aggregation

    K Number
    K992360
    Device Name
    TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    TG MEDICAL SDN BHD
    Date Cleared
    1999-10-12

    (89 days)

    Product Code
    LZA
    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

    POWDERED NITRILE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

    Device Description

    POWDERED NITRILE EXAMINATION GLOVES

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Powdered Nitrile Examination Gloves", indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classifications, general controls, and good manufacturing practices, but not specific performance acceptance criteria or study details.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number of experts and their qualifications for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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