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510(k) Data Aggregation

    K Number
    K994281
    Device Name
    BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
    Manufacturer
    BIOPRO (M) SDN BHD
    Date Cleared
    2000-10-20

    (305 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

    Biopro™, Nitrilon™, Correct Touch (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Biopro™, Nitrilon™, Correct Touch or any other private labeling Nitrile Powder Free Examination Gloves (Green, Purple)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a medical device. The document is an FDA 510(k) clearance letter for examination gloves, which primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "general controls" and "good manufacturing practice" but does not detail specific performance criteria or a study proving those criteria are met.

    Therefore, I cannot provide the requested information based on the given input.

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