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

    LUBRICATED CONDOM

    K Number: K872504 · Decision Nov 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    398
    Applicant Total
    2
    Review Days
    149

    Basic Information

    Device Name
    LUBRICATED CONDOM
    K Number
    K872504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    ROYAL AMERICAN INDUSTRIES, INC.
    Date Received
    June 24, 1987
    Decision Date
    November 20, 1987
    Product Code
    HIS
    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
    HIS Condom

    Similar 510(k) Clearances

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

    Natural rubber latex male condom

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

    Lelo Hex Lubricated Natural Rubber Latex Condom

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

    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

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

    0.04 ZERO ZERO FOUR Male Latex Condom

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

    LifeStyles NRL Textured Condom

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

    SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

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

    Other Clearances by ROYAL AMERICAN INDUSTRIES, INC.

    K Number Device Name
    K874464 SPERMICIDAL CONDOM