BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇭 Switzerland

    Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs

    K Number: K173386 · Decision Apr 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    9
    Review Days
    161

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    Basic Information

    Device Name
    Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
    K Number
    K173386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lucenxia Prescience AG
    Date Received
    October 30, 2017
    Decision Date
    April 9, 2018
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Lucenxia Prescience AG

    K Number Device Name
    K173304 Finessis Intense Polyisoprene Surgical Glove
    K171987 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
    K162852 Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
    K151607 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
    K151605 Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
    K131751 FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
    K123629 FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
    K123628 STERILE LATEX SURGICAL GLOVE