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    K Number
    K160709
    Device Name
    HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
    Manufacturer
    Halyard Health
    Date Cleared
    2016-09-06

    (176 days)

    Product Code
    LZC
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K113423
    Why did this record match?
    Reference Devices :

    K113423

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes.

    Device Description

    HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for HALYARD PURPLE NITRILE – XTRA Powder-Free Exam Gloves**, specifically regarding their resistance to chemotherapy drugs and other physical properties.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test StandardAcceptance CriteriaReported Device Performance
    ASTM D6978-05: Resistance to Permeation by Chemotherapy DrugsNo signs of breakthrough after 4 hours (>240 minutes) for most drugs. Specific breakthrough time for Carmustine set at 30.7 minutes for predicate device.No breakthrough observed for most chemotherapy drugs up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes (at 3.3 mg/ml concentration). This exceeds the predicate's Carmustine breakthrough time of 30.7 minutes, indicating improved performance.
    ASTM D5151-06: Detection of Holes in Medical Gloves2.5% AQL (Acceptable Quality Level) for leakage.Meets the 2.5% AQL requirement. (Halyard Specification: AQL 1.0%)
    ASTM D6124-06: Residual Powder on Medical Gloves
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