BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

    K Number: K972836 · Decision Oct 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    83

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    Basic Information

    Device Name
    ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
    K Number
    K972836
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G. Premjee (Usa), Inc.
    Date Received
    July 31, 1997
    Decision Date
    October 22, 1997
    Product Code
    LTZ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTZ Condom With Nonoxynol-9

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LTZ), ordered by most recent decision date.

    CAUTION CONDOMS

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    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

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    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

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    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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    View all

    Other Clearances by G. Premjee (Usa), Inc.

    K Number Device Name
    K971132 ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS