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    K Number
    K112089
    Device Name
    BIOGEL ORTHOPOR BROWN SURGICAL GLOVE
    Manufacturer
    MOLNLYCKE HEALTHCARE, US LLC
    Date Cleared
    2011-08-24

    (34 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    K071700,K071465
    Why did this record match?
    Device Name :

    BIOGEL ORTHOPOR BROWN SURGICAL GLOVE

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

    The Biogel® OrthoPro® Brown Surgical Glove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

    Device Description

    The proposed device, the Biogel® OrthoPro® Brown Surgical Glove is manufactured of natural rubber latex colored with brown nigmentation. The Biogel® OrthoPro® Brown Surgical Glove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years with the addition of the brown colorant. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Brown Surgical Glove to provide the user with this additional feature: Slightly Curved Former with Independent/Displaced thumb.

    AI/ML Overview

    The document describes the Biogel® OrthoPro® Brown Surgical Glove.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (requirements from ASTM D3577, 21 CFR 800.20, and ASTM D5712)Reported Device Performance (Result)
    Primary Skin IrritationNot explicitly stated (implied non-irritating)Gloves are non-irritating.
    ISO Closed Patch SensitizationNot explicitly stated (implied no sensitization potential)Gloves do not display any potential for sensitization.
    DimensionsRequirements of ASTM D3577Gloves meet requirements of ASTM D3577.
    Physical PropertiesRequirements for rubber surgical gloves per ASTM D3577Gloves meet requirements for rubber surgical gloves per ASTM D3577.
    Freedom from HolesRequirements of 21 CFR 800.20 and ASTM D3577Gloves exceed the requirements of 21 CFR 800.20 and ASTM D3577.
    Protein ExtractablesRequirements of ASTM D5712Gloves meet requirements of ASTM D5712.
    Powder ResidualPowder level requirements for "Powder-Free" designation per ASTM D3577 (using ASTM standard D6142, presumably
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