BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE

    K Number: K002220 · Decision Aug 15, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
    K Number
    K002220
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shanghai Champion Plastic Products Co., Ltd.
    Date Received
    July 24, 2000
    Decision Date
    August 15, 2000
    Product Code
    LZA
    Advisory Committee
    General Hospital
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Shanghai Champion Plastic Products Co., Ltd.

    K Number Device Name
    K002218 NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
    K002217 NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
    K002216 NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
    K994136 POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
    K994036 PRE-POWDERED VINYL EXAM GLOVE, NON STERILE