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510(k) Data Aggregation

    K Number
    K193573
    Device Name
    Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
    Manufacturer
    Molnlycke Health Care US LLC.
    Date Cleared
    2020-04-10

    (109 days)

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

    Molnlycke Health Care US LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.
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