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510(k) Data Aggregation

    K Number
    K192203
    Device Name
    JO for Him H2O Gel Original Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2020-02-10

    (180 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO for Him H2O Gel Original Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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
    JO for Him H2O Gel Original Personal Lubricant is a clear/water white, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 4 oz. and 8 oz. sizes provided in matte black, polyethylene (PE) tubes. These tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. This device is composed of Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Methylparaben, Propylparaben, Hydroxyethylcellulose and Sodium Hydroxide.
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    K Number
    K190858
    Device Name
    Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-09-18

    (169 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bucked Stride Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. #LubeLife Thin Silicone Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a silicone-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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
    Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant and JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant are clear, thin, liquid personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The Bucked Stride Silicone Lubricant product is to be sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear polyethylene terephthalate (PET) cylinder bottles are capped with matte black pumps covered with a metallic coated polypropylene (PP) overcap and shrink wrapped to ensure product integrity. #LubeLife Thin Silicone Lubricant is to be sold as an over-the-counter (OTC) product in 8 fl. oz./240 mL size bottles. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles and capped with natural disc tops. The individual bottles are hermetically sealed during the production process. JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is to be sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in clear, polyethylene terephthalate (PET) cylinder bottles. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
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    K Number
    K191214
    Device Name
    JO Premium Jelly Original Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-08-01

    (87 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Premium Jelly Original Personal Lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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, polyurethane and polyisoprene condoms.
    Device Description
    JO Premium Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.
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    K Number
    K182585
    Device Name
    JO Actively Trying Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-04-26

    (218 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.
    Device Description
    JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.
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    K Number
    K183584
    Device Name
    JO H2O Jelly Original Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-04-17

    (117 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO H2O Jelly Original Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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
    JO H2O Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process.
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    K Number
    K183384
    Device Name
    JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2019-03-04

    (88 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Agapé Original Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. MUSE Essence Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms. #LubeLife Water-Based Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. #LubeLife Water-Based Anal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber lates and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    JO Agapé Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant and #LubeLife Water-Based Anal Lubricant are clear/water white, viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. All of these devices contain the same formulation.
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    K Number
    K182105
    Device Name
    JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2018-11-14

    (103 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyurethane and polyisoprene condoms.
    Device Description
    JO Naturalove Personal Lubricant and JO Naturalove Strawberry Fields Flavored Personal Lubricant are clear, viscous, amber colored, gel type personal lubricants that are compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Both versions of the subject device have the same formulation, with the exception of the addition of a fragrance to the JO Naturalove Strawberry Fields Flavored Personal Lubricant. These devices are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in 0.1 oz and 0.3 oz polyester-faced laminated pouches.
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    K Number
    K181408
    Device Name
    JO Classic Hybrid Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2018-08-27

    (89 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO Classic Hybrid Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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
    JO Classic Hybrid Personal Lubricant is an off-white, semi-viscous, translucent gel type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural polypropylene disc top dispenser caps. The 2 oz., 4 oz. and 8 oz. size bottles are capped with silver polypropylene disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
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    K Number
    K180712
    Device Name
    Coconut Infused Hybrid Personal Lubricant
    Manufacturer
    United Consortium
    Date Cleared
    2018-06-06

    (79 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coconut Infused Hybrid Personal Lubricant is a water-based personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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
    Coconut Infused Hybrid Personal Lubricant is a translucent cream, white to off-white in color, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This device is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. This product is also available in polyester-faced laminated pouches.
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    K Number
    K180219
    Device Name
    JO H2O Flavored Personal Lubricants
    Manufacturer
    United Consortium
    Date Cleared
    2018-04-20

    (85 days)

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

    United Consortium

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JO H2O Flavored Personal Lubricants are water-based personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
    Device Description
    JO H2O Flavored Personal Lubricants are clear, semi-viscous personal lubricants that are compatible with condoms made of natural rubber latex and polyisoprene. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles. The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. size bottles are capped with silver disc top dispenser caps. The individual bottles are hermetically sealed during the production process. These products are also available in polyester-faced laminated pouches.
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