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510(k) Data Aggregation

    K Number
    K020633
    Device Name
    NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
    Manufacturer
    LS RUBBER SDN BHD
    Date Cleared
    2002-05-15

    (77 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LS RUBBER SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
    Device Description
    This condom is made of a natural rubber sheath, which completely covers the penis with a closely fitted membrane. This condom has smooth or textured surface, parallel-sided ,reservoir ended condoms with an integral bead at the open end. The nominal length is minimum 180 mm, the width is 52 or 53 +/- 2 mm and 0.03 mm minimum for the thickness.
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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?
    Applicant Name (Manufacturer) :

    LS RUBBER SDN BHD

    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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    K Number
    K980964
    Device Name
    MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
    Manufacturer
    LS RUBBER SDN BHD
    Date Cleared
    1999-03-12

    (361 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LS RUBBER SDN BHD

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