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

    MALA LATEX EXAM GLOVES AND SCAN-SUB

    K Number: K946154 · Decision Jan 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    26

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    Basic Information

    Device Name
    MALA LATEX EXAM GLOVES AND SCAN-SUB
    K Number
    K946154
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lowenkamp Intl., Inc.
    Date Received
    December 16, 1994
    Decision Date
    January 11, 1995
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Lowenkamp Intl., Inc.

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