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    K Number
    K121335
    Device Name
    G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
    Manufacturer
    HUTCHINSON SANTE S.N.C.
    Date Cleared
    2012-09-13

    (133 days)

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

    HUTCHINSON SANTE S.N.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.
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