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

    SUNTEX STERILE EXAM GLOVES

    K Number: K910631 · Decision Mar 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    22

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    Basic Information

    Device Name
    SUNTEX STERILE EXAM GLOVES
    K Number
    K910631
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    P.T. Latexindo Prautama
    Date Received
    February 13, 1991
    Decision Date
    March 7, 1991
    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 P.T. Latexindo Prautama

    K Number Device Name
    K900296 SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES
    K892478 SAFETEX & SUNTEX PATIENT EXAMINATION GLOVES