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510(k) Data Aggregation

    K Number
    K141059
    Device Name
    NATURAL RUBBER LATEX MALE CONDOMS
    Manufacturer
    KAREX INDUSTRIES SDN BHD
    Date Cleared
    2014-08-01

    (99 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Natural Rubber Latex Male Condoms [Parallel Sided, Smooth, Lubricated or Non-lubricated] a) Parallel Sided Smooth, 53mm Condoms b) Parallel Sided Smooth, 53mm Condoms - Ultra Thin c) Parallel Sided Smooth, 53mm Condoms - Super Thin d) Parallel Sided Smooth, 56mm Condoms e) Parallel Sided Smooth, 56mm Condoms - Ultra Thin The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Natural Rubber Latex Male Condoms [Parallel Sided, Smooth, Lubricated or Non-lubricated]
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    K Number
    K132597
    Device Name
    BLACK COLOURED CONDOM
    Manufacturer
    KAREX INDUSTRIES SDN BHD
    Date Cleared
    2013-11-25

    (98 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Colored Condoms [Parallel Sided or Contoured or Flared or Non-textured, Lubricated or Non-lubricated] a) Parallel sided smooth, 53mm Black colored condom b) Parallel sided dotted, 53mm Black colored condom c} Parallel sided ribbed, 53mm Black colored condom d) Parallel sided smooth, 56mm Black colored condom e) Contoured studded, 53mm Black colored condom f) Contoured ribbed & studded, 53mm Black colored condom g) Contoured ribbed, 52mm Black colored condom h) Flared smooth, 56mm Black colored condom The Karex condom is used for contraceptive 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
    K113056
    Device Name
    ORANGE COLORED CONDOMS ORANGE SCENT
    Manufacturer
    KAREX INDUSTRIES SDN BHD
    Date Cleared
    2012-07-03

    (263 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
    Device Description
    Orange colored condoms with orange scents
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    K Number
    K113061
    Device Name
    LARGE/EXTRA LAGRE CONDOM
    Manufacturer
    KAREX INDUSTRIES SDN BHD.
    Date Cleared
    2011-12-07

    (54 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karex Large and Extra Large condom is used for contraceptive 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
    K081886
    Device Name
    KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
    Manufacturer
    KAREX INDUSTRIES SDN BHD
    Date Cleared
    2009-02-06

    (219 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karex 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 rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight sided or contoured , textured or non textured ,with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.07mm. It is nonlubricated or lubricated with silicone and cornstarch is used as a dressing material. The condom is either colored or non colored, flavored or non flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
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    K Number
    K070830
    Device Name
    MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
    Manufacturer
    KAREX INDUSTRIES SDN BHD
    Date Cleared
    2007-05-08

    (43 days)

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

    KAREX INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karex 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 rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight walled, contoured or flared with a reservoir tip; nominal length 180mm, nominal width 53mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The 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

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