BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KIMBERLY-CLARK CHILD'S FACEMASK

    K Number: K113340 · Decision May 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    172

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    Basic Information

    Device Name
    KIMBERLY-CLARK CHILD'S FACEMASK
    K Number
    K113340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark
    Date Received
    November 14, 2011
    Decision Date
    May 4, 2012
    Product Code
    OXZ
    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
    OXZ Pediatric/Child Facemask

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    Other Clearances by Kimberly-Clark

    K Number Device Name
    K112562 BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
    K111402 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
    K103150 KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
    K101596 KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-