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

    ONE Male Condom

    K Number: DEN210034 · Decision Feb 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    11
    Review Days
    181

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    Basic Information

    Device Name
    ONE Male Condom
    K Number
    DEN210034
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    884.5305
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Global Protection Corp.
    Date Received
    August 26, 2021
    Decision Date
    February 23, 2022
    Product Code
    QRZ
    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
    QRZ External Condom For Anal Intercourse Or Vaginal Intercourse

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