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510(k) Data Aggregation

    K Number
    K062764
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
    Manufacturer
    KOSSAN LATEX INDUSTRIES(M)SDN BHD
    Date Cleared
    2007-02-27

    (165 days)

    Product Code
    LZC,LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K111772,K121947
    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 pariesoo and examiner. This device is not intended to be used as a chemical barrier.

    Device Description

    Powder-free Nitrile Patient Examination Glove, White (non-colored) and Blue Colored, Tested for use with Chemotherapy Drugs

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Tested for use with Chemotherapy Drugs.

    The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications).

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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