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510(k) Data Aggregation

    K Number
    K052636
    Manufacturer
    Date Cleared
    2005-11-10

    (45 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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 healthca personnel and patient.

    Device Description

    Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for "Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow." It does not include information about acceptance criteria or a study proving that a device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations that apply. It details the device name, regulation number, product code, and indications for use.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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