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510(k) Data Aggregation

    K Number
    K033163
    Device Name
    CAUTION CONDOMS
    Manufacturer
    RICHARD VAN HAUSSEN AMERICA, INC.
    Date Cleared
    2004-04-27

    (172 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
    Device Description
    Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9
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    K Number
    K012969
    Device Name
    DOUBLE SPRINGERS NONOXNOL 9 CONDOM
    Manufacturer
    MEDTECH PRODUCTS LTD.
    Date Cleared
    2002-06-12

    (281 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Double Springers Nonoxynol 9 condom, is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
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    K Number
    K010178
    Device Name
    SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-04-27

    (98 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003375
    Device Name
    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
    Manufacturer
    TECNILATEX S.A.
    Date Cleared
    2001-01-28

    (90 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001978
    Device Name
    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2000-08-08

    (40 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001377
    Device Name
    SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2000-06-08

    (38 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992438
    Device Name
    INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
    Manufacturer
    INDUS MEDICARE LTD.
    Date Cleared
    1999-08-02

    (11 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Invigra Plus condom is used for contraception and for prophytic purposes. Invigra Plus Condoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.
    Device Description
    Invigra Plus (With Spermicidal Lubricant) - Male Natural Rubber Latex Condom
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    K Number
    K991047
    Device Name
    HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
    Manufacturer
    HARDCOVER PRODUCTS, INC.
    Date Cleared
    1999-06-18

    (80 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).
    Device Description
    Not Found
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    K Number
    K990669
    Device Name
    MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
    Manufacturer
    DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD.
    Date Cleared
    1999-05-17

    (76 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THESE DIFFERENT TYPES (NATURAL ORDINARY, NATURAL RIBBED, NATURAL DOTTED, AND NATURAL CONTOURED) OF NATURAL LATEX RUBBER CONDON (WITH NONOXYNOL-9) ARE USED FOR CONTRACEPTION AND FOR PROPHYLACTIC PURPOSES (TO PREVENT PREGNANCY AND THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD'S).
    Device Description
    Natural Ordinary, Natural Ribbed, Natural Dotted and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9)
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    K Number
    K981955
    Device Name
    MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
    Manufacturer
    LS RUBBER SDN BHD
    Date Cleared
    1999-03-15

    (284 days)

    Product Code
    LTZ
    Regulation Number
    884.5310
    Why did this record match?
    Product Code :

    LTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of these latex coloured condoms with spermicidal lubricant is for contraception and prophylactics purposes (preventing transmission of venereal diseases.)
    Device Description
    Colored Latex Condom with Spermicidal Lubricant (Maxima, Trustex, Ria, Premium and, EL LES Condoms)
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