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

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    K Number: K001377 · Decision Jun 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    10
    Review Days
    38

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    Basic Information

    Device Name
    SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    K Number
    K001377
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pleasure Latex Products Sdn. Bhd.
    Date Received
    May 1, 2000
    Decision Date
    June 8, 2000
    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

    INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

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

    Other Clearances by Pleasure Latex Products Sdn. Bhd.

    K Number Device Name
    K022156 LATEX ULTRASONIC PROBE COVER
    K023333 MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
    K021875 MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
    K020272 MALE LATEX CONDOM WITH RIBBED SURFACE
    K002571 MULITPLE MALE LATX CONDOM
    K001221 MALE LATEX COMDOM WITH DOTTED SURFACE
    K994312 MALE LATEX CONDOM 56MM
    K994311 MALE LATEX CONDOM WITH VANILLA FLAVOR
    K982380 SURE