LogoFDA 510(k) Search
Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K053367
    Device Name
    MALE NATURAL RUBBER LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2006-02-21

    (78 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE [No particular brand name] condom is used for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Male Natural Rubber Latex Condom
    Ask a Question
    K Number
    K041837
    Device Name
    INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2004-09-24

    (79 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innolatex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled or contoured with a reservoir tip; nominal length 180mm, nominal width 52mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
    Ask a Question
    K Number
    K012664
    Device Name
    ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (88 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Ultra Thick Male Latex Condom with Silicone Lubricant
    Ask a Question
    K Number
    K012665
    Device Name
    ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (88 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
    Ask a Question
    K Number
    K012962
    Device Name
    DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (66 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
    Ask a Question
    K Number
    K012964
    Device Name
    56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-11-09

    (66 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Not Found
    Ask a Question
    K Number
    K010919
    Device Name
    MALE NATURAL RUBBER LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2001-06-15

    (80 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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?
    Applicant Name (Manufacturer) :

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002393
    Device Name
    NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    Manufacturer
    INNOLATEX SDN. BHD
    Date Cleared
    2000-12-19

    (134 days)

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

    INNOLATEX SDN. BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1