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

    SIME HEALTH SIME HYPOALLERGENIC

    K Number: K931491 · Decision Oct 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    11
    Review Days
    204

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    Basic Information

    Device Name
    SIME HEALTH SIME HYPOALLERGENIC
    K Number
    K931491
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sime Health, Ltd.
    Date Received
    March 25, 1993
    Decision Date
    October 15, 1993
    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 Sime Health, Ltd.

    K Number Device Name
    K954025 SIME SURGICAL POWDERFREE
    K954051 SIME POWDERFREE PLUS
    K932985 AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI
    K932983 COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
    K932982 SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
    K932984 UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI
    K940797 SIME SURGICAL LATEX GLOVE
    K914276 SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES
    K913813 JIFFI CONDOM (RUBBER) CONTRACEPTIVE
    K913048 SIME TRUFEEL
    Search all 11 clearances from Sime Health, Ltd. →