BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇭 Thailand

    LifeStyles NRL Textured Condom

    K Number: K232279 · Decision Oct 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    66

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LifeStyles NRL Textured Condom
    K Number
    K232279
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suretex Limited
    Date Received
    July 31, 2023
    Decision Date
    October 5, 2023
    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.

    Male Latex Condom HA

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

    LifeStyles® HydraFeel Natural Rubber Latex Condom

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

    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
    View all

    Other Clearances by Suretex Limited

    K Number Device Name
    K252521 LifeStyles® HydraFeel Natural Rubber Latex Condom
    K232470 Polyisoprene Extra Large Condom
    K231908 45 Micron Polyisoprene Condom
    K221243 OFNat Lubricant (L15)
    K213921 Microthin Natural Rubber Latex Condom