Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K111413
    Device Name
    BIOGEL (R) INDICATOR (R) UNDERGLOVE
    Manufacturer
    MOLNLYCKE HEALTHCARE, US LLC
    Date Cleared
    2012-01-30

    (255 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTHCARE, US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene, blue in color, 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 PI Indicator Underglove is manufactured of polyisoprene colored with blue pigmentation. The Biogel PI Indicator Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device that has been legally marketed by Molnlycke Health Care for many years with the addition of a surfactant.
    Ask a Question
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTHCARE, US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
    Ask a Question
    K Number
    K071465
    Device Name
    BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
    Manufacturer
    MOLNLYCKE HEALTHCARE, US LLC
    Date Cleared
    2007-09-11

    (105 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTHCARE, US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biogel Orthopedic Surgeon's 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 Biogel Orthodepic Surgical Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
    Ask a Question
    K Number
    K071700
    Device Name
    BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
    Manufacturer
    MOLNLYCKE HEALTHCARE, US LLC
    Date Cleared
    2007-09-11

    (82 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTHCARE, US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biogel® Sensor™ Surgeon's Glove is a sterile 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 Biogel® Sensor™ Surgeon's Glove is a sterile powder free, polymer coated latex surgical glove. The glove contains 50 micrograms or less of total water extractable protein per gram.
    Ask a Question

    Page 1 of 1