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

    PB PLUS LEAD LATEX GLOVES

    K Number: K896759 · Decision Mar 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    116

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    Basic Information

    Device Name
    PB PLUS LEAD LATEX GLOVES
    K Number
    K896759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sistem Med-Pro (M) Sdn Bhd
    Date Received
    December 1, 1989
    Decision Date
    March 27, 1990
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Sistem Med-Pro (M) Sdn Bhd

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