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510(k) Data Aggregation

    K Number
    K242162
    Device Name
    Coconut Hybrid
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2024-09-19

    (57 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Coconut Hybrid is a personal lubricant for 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    Coconut Hybrid is a water-based personal lubricant that is non- sterile, contains coconut oil, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, fractionated coconut oil, tremella fuciformis extract, hyaluronic acid, propanediol, DL lactic acid, xanthan gum, sodium benzoate, potassium sorbate, and natural coconut flavor. Coconut Hybrid is packaged in a 50 mL polyethylene tubes and is a personal lubricant for over the counter (OTC) use.
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    K Number
    K211998
    Device Name
    Desnuda Reflect
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2021-11-18

    (143 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Desnuda Reflect 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
    Desnuda Reflect is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.
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    K Number
    K212000
    Device Name
    Medley
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2021-11-18

    (143 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medley 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
    Medley is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, xanthan gum, hyaluronic acid, Zemea propanediol, glycerin water, dimethicone, hydrogenated lecithin, sodium benzoate, potassium sorbate, and DL lactic acid. Medley is packaged in 2 fl. oz high-density polyethylene pump bottles. Medley is a personal lubricant for over-the-counter (OTC) use.
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    K Number
    K193448
    Device Name
    BioNourish Lubricant
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2020-03-12

    (90 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioNourish Lubricant 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
    BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.
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    K Number
    K190872
    Device Name
    BioGenesis Fertility Lubricant
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2019-11-07

    (218 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioGenesis Fertility Lubricant 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. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
    Device Description
    BioGenesis Fertility Lubricant is water-based formula with ingredients including lactic acid, hydroxyethylcellulose, sodium chloride, potassium sorbate, sodium benzoate, potassium chloride, sorbic acid, magnesium chloride, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications are listed in Table 1 below. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. It is also compatible with compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples.
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    K Number
    K180136
    Device Name
    BioNude Lubricant
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2018-06-01

    (135 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioNude 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. It is not compatible with polyurethane condoms.
    Device Description
    BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
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    K Number
    K150094
    Device Name
    Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
    Manufacturer
    Good Clean Love, Inc.
    Date Cleared
    2015-11-19

    (307 days)

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

    Good Clean Love, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Good Clean Love Personal Lubricant Almost Naked and Natural Cinnamon Vanilla are 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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
    Device Description
    Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla contain water-solvent organic materials. The primary ingredient is aloe vera (95%). The products are provided in tube containers and have a gel consistency. They include aromatics of cinnamon, vanilla, and lemon. The lubricants are not a spermicide or contraceptive. They are compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
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