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510(k) Data Aggregation

    K Number
    K993049
    Device Name
    DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    1999-11-19

    (70 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 :

    DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES

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

    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for "DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    The information provided does not contain details about acceptance criteria, a study proving the device meets those criteria, or any of the specific points requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).

    This document is solely an FDA clearance letter for a medical device (examination gloves), indicating that it can be legally marketed. It does not contain the kind of performance data or study details you are asking for, which would typically be found in a separate study report or regulatory submission appendix.

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