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    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    GLOVETEX (MULTIPLE)

    K Number: K952197 · Decision Aug 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    GLOVETEX (MULTIPLE)
    K Number
    K952197
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pt Mbf Buana Multicorpora
    Date Received
    May 9, 1995
    Decision Date
    August 14, 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 Pt Mbf Buana Multicorpora

    K Number Device Name
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