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510(k) Data Aggregation

    K Number
    K142790
    Device Name
    OneTouch Lubricant Gel
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2015-07-30

    (307 days)

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

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.
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    K Number
    K081265
    Device Name
    THAI NIPPON MALE LATEX CONDOM
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2009-10-16

    (529 days)

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

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thai Nippon Male Latex Condom is used for contraception 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 erect penis with a closely fitted membrane. This condom is colorless, smooth, flared at the closed end with a reservoir tip; nominal lav flat width 56mm, nominal length 200 mm, and nominal thickness 0.07mm. It is lubricated with silicone (viscosity 250 cps), and cornstarch is used as a dressing material. This condom conforms to current established national and international voluntary standards including ASTM D3492:2008 and ISO 4074:2002.
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    K Number
    K032909
    Device Name
    THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2003-12-16

    (90 days)

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

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011253
    Device Name
    FLAVORED MALE LATEX CONDOM
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2001-07-20

    (87 days)

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

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    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?
    Applicant Name (Manufacturer) :

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994095
    Device Name
    LATEX CONDOM
    Manufacturer
    THAI NIPPON RUBBER INDUSTRY CO., LTD.
    Date Cleared
    2000-01-18

    (46 days)

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

    THAI NIPPON RUBBER INDUSTRY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thai Nippon condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and 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 with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. The condom is offered in natural latex color, red, blue, green, and yellow.
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