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

    SIME SURGICAL LATEX GLOVE

    K Number: K940797 · Decision May 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    11
    Review Days
    76

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    Basic Information

    Device Name
    SIME SURGICAL LATEX GLOVE
    K Number
    K940797
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sime Health, Ltd.
    Date Received
    February 22, 1994
    Decision Date
    May 9, 1994
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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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
    K931491 SIME HEALTH SIME HYPOALLERGENIC
    K914276 SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES
    K913813 JIFFI CONDOM (RUBBER) CONTRACEPTIVE
    K913048 SIME TRUFEEL
    Search all 11 clearances from Sime Health, Ltd. →