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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
    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
    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
    K032227
    Device Name
    DUREX FLAVORED LATEX CONDOM
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2004-03-29

    (252 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
    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 colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.
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    K Number
    K040353
    Device Name
    FLIGHT SOCK
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2004-03-11

    (28 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SSL AMERICAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. Over the Counter
    Device Description
    SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.
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    K Number
    K032124
    Device Name
    DUREX PLAY LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2004-01-16

    (190 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
    Durex Play™ 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™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
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    K Number
    K020659
    Device Name
    DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
    Manufacturer
    SSL AMERICAS, INC.
    Date Cleared
    2002-03-29

    (28 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
    The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.
    Device Description
    DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.
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