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510(k) Data Aggregation

    K Number
    K990267
    Device Name
    POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
    Manufacturer
    SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
    Date Cleared
    1999-03-29

    (60 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

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

    Device Description

    POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Powdered Blue Nitrile Medical Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include performance data or studies that would detail acceptance criteria for a device's performance.

    Therefore, I cannot extract the requested information from the provided text.

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