BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

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

    K Number: K981621 · Decision Jun 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    3
    Review Days
    44

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    Basic Information

    Device Name
    ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
    K Number
    K981621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suretex Prophylactics (India) , Ltd.
    Date Received
    May 6, 1998
    Decision Date
    June 19, 1998
    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

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DOUBLE SPRINGERS NONOXNOL 9 CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Suretex Prophylactics (India) , Ltd.

    K Number Device Name
    K992081 VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
    K983320 ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS