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510(k) Data Aggregation

    K Number
    K111878
    Device Name
    PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2011-09-29

    (90 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K053272
    Why did this record match?
    Device Name :

    PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES

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

    This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

    Device Description

    The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance CriteriaReported Device Performance
    Biocompatibility:
    Primary Skin IrritationISO 10993-10 (Pass)Gloves are non-irritating. (Meets requirements)
    Guinea Pig MaximizationISO 10993-10 (Pass)Gloves do not display any potential for sensitization. (Meets requirements)
    Physical Characteristics:
    DimensionsASTM D3577 requirementsMeet requirements. (Meets requirements for rubber surgical gloves)
    Physical PropertiesASTM D3577 requirementsMeet requirements for rubber surgical gloves. (Meets requirements)
    Freedom from HolesAQL meets 21CFR 800.20 & ASTM D3577 requirementsTested in accordance with ASTM D5151 with acceptable results. (Meets requirements)
    Powder Residual≤2.0 mg/glove for Powder-Free designation per ASTM D3577**Gloves meet powder level requirements for "Powder-Free" designation per ASTM D3577. Results generated values
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