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510(k) Data Aggregation

    K Number
    K990946
    Device Name
    BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
    Manufacturer
    LONG FIRST (XIAMEN) CO.,LTD.
    Date Cleared
    1999-05-04

    (43 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 :

    BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES

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

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

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for "Brothers Vinyl, Powdered, Patient Examination Gloves," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

    The document discusses:

    • The FDA's review and determination of substantial equivalence.
    • Regulatory classification (Class I).
    • Applicable general controls provisions of the Act (annual registration, listing, GMP, labeling, misbranding, adulteration).
    • Contact information for various FDA offices.
    • The "Indications For Use" statement for the medical gloves.

    There is no mention of specific performance metrics, acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot extract the information you requested based on the input provided.

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