BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    K Number: K010178 · Decision Apr 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    9
    Review Days
    98

    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
    SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    K Number
    K010178
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innolatex Sdn. Bhd
    Date Received
    January 19, 2001
    Decision Date
    April 27, 2001
    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

    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

    INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

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

    Other Clearances by Innolatex Sdn. Bhd

    K Number Device Name
    K053367 MALE NATURAL RUBBER LATEX CONDOM
    K041837 INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
    K012665 ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
    K012964 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
    K012664 ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
    K012962 DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
    K010919 MALE NATURAL RUBBER LATEX CONDOM
    K002393 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM