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510(k) Data Aggregation

    K Number
    K102620
    Device Name
    POWDERFREE BLACK NITRILE EXAMINATION GLOVES
    Manufacturer
    PT. MEDISAFE TECHNOLOGIES
    Date Cleared
    2010-11-22

    (70 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 purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Black Nitrile Examination Gloves

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for "Powder Free Black Nitrile Examination Gloves." It does not contain any information about an AI/ML device, its acceptance criteria, or a study proving its performance.

    Therefore, I cannot provide the requested information about acceptance criteria and a study from this document. The document primarily focuses on regulatory approval for a physical medical device (gloves) based on substantial equivalence to existing products.

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