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510(k) Data Aggregation

    K Number
    K072169
    Device Name
    DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2008-06-19

    (318 days)

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

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex synthetic polyisoprene male 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 synthetic polyisoprene rubber sheath, which completely I his condom is made or lead of the membrane. This device is a shaped, teat ended, lubricated condom. Synthetic polyisoprene is the synthetic form of natural lubricated condom. Bylinene perfisen as natural rubber, a material commonly used for poryisoprono raover of condoms made by SSL from synthetic polyisoprene have been shown to have similar performance properties as natural rubber latex condoms and conform to the relevant physical test requirements of national and international connomi to tare referant patural rubber latex male condoms, ISO 4074:2002, and Volunary Sandards of the synthetic condom standard ASTM D6324-05.
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    K Number
    K072236
    Device Name
    DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
    Manufacturer
    SSL AMERICAS
    Date Cleared
    2008-05-07

    (271 days)

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

    SSL AMERICAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Play™ Tingling aqueous based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is only compatible with natural rubber latex condoms.
    Device Description
    Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.
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    K Number
    K071626
    Device Name
    DUREX PLAY SOFT & SENSUAL LUBRICANT
    Manufacturer
    SSL AMERICAS
    Date Cleared
    2008-04-01

    (292 days)

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

    SSL AMERICAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile 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 condoms only.
    Device Description
    Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.
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    K Number
    K063385
    Device Name
    DUREX PLAY MASSAGE GEL LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2008-03-10

    (488 days)

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

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.
    Device Description
    Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.
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    K Number
    K060098
    Device Name
    DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2006-06-08

    (146 days)

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

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
    Device Description
    Durex Play™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.
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    K Number
    K052959
    Device Name
    DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS
    Manufacturer
    SSL AMERICAS
    Date Cleared
    2006-01-27

    (98 days)

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

    SSL AMERICAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
    Device Description
    The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight walled , teat ended, coloured condom containing either red, yellow, orange or green pigment. The condoms are lubricated with a water based flavoured lubricant containing either lychee, guava, pineapple, mango or kiwi scent. The device is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492-03.
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    K Number
    K042958
    Device Name
    DUREX PLAY TINGLING LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2005-04-08

    (163 days)

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

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Play™ Tingling Lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
    Device Description
    Durex Play™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.
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    K Number
    K042470
    Device Name
    DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2005-04-05

    (204 days)

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

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Durex latex 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 latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.
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    K Number
    K042563
    Device Name
    DUREX PLAY WARMER LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2005-02-23

    (155 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    SSL AMERICAS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Play™ Warmer™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
    Device Description
    Durex Play Warmer™ is a clear colorless personal lubricant composed of Purified Water, Hydroxyethyl Cellulose (Natrosol 250), Propylene Glycol, Benzoic Acid, Sodium Hydroxide, Sodium Saccharin, Glycerol.
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    K Number
    K042957
    Device Name
    DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
    Manufacturer
    SSL AMERICAS
    Date Cleared
    2005-02-17

    (113 days)

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

    SSL AMERICAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex latex condom used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
    Device Description
    The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.
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