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510(k) Data Aggregation

    K Number
    K121897
    Device Name
    PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2012-07-27

    (28 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K120934
    Why did this record match?
    Device Name :

    PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES

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

    A powder-free sterile 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 and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves (Cream), based on the provided text:

    Acceptance Criteria and Device Performance

    The device is a modified version of an already cleared predicate device (K120934). The primary modification is the removal of colorant from the glove formulation. The acceptance criteria and performance are based on meeting established industry standards for surgical gloves and demonstrating substantial equivalence to the predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Characteristic / Acceptance CriteriaStandard/Test/FDA GuidanceReported Device Performance (Modified Device)
    Material CompositionN/A (Comparative Characteristic)Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm² or less (Cream)
    DesignN/A (Comparative Characteristic)Single Use, Sterile, Powder-free, Hand Specific, Independent Thumb, Beaded Cuff, Lubricated
    Intended Use/Indications for UseN/A (Comparative Characteristic)Powder-Free Surgeon's Glove
    Dimensions & Physical PropertiesASTM D3577Meet requirements
    Freedom from Holes (AQL)21 CFR 800.20 & ASTM D3577 (Tested per ASTM D5151)Meets requirements (acceptable results)
    Powder ResidualASTM D3577 (Tested per ASTM D6124)Meets requirements of ≤2.0 mg/glove for "Powder-Free" designation. Results generated values
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