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Found 7 results
510(k) Data Aggregation
K Number
K242162Device Name
Coconut Hybrid
Manufacturer
Good Clean Love, Inc.
Date Cleared
2024-09-19
(57 days)
Product Code
NUC
Regulation Number
884.5300Why 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
K211998Device Name
Desnuda Reflect
Manufacturer
Good Clean Love, Inc.
Date Cleared
2021-11-18
(143 days)
Product Code
NUC
Regulation Number
884.5300Why 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
K212000Device Name
Medley
Manufacturer
Good Clean Love, Inc.
Date Cleared
2021-11-18
(143 days)
Product Code
NUC
Regulation Number
884.5300Why 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
K193448Device Name
BioNourish Lubricant
Manufacturer
Good Clean Love, Inc.
Date Cleared
2020-03-12
(90 days)
Product Code
NUC
Regulation Number
884.5300Why 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
K190872Device Name
BioGenesis Fertility Lubricant
Manufacturer
Good Clean Love, Inc.
Date Cleared
2019-11-07
(218 days)
Product Code
PEB
Regulation Number
884.5300Why 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
K180136Device Name
BioNude Lubricant
Manufacturer
Good Clean Love, Inc.
Date Cleared
2018-06-01
(135 days)
Product Code
NUC
Regulation Number
884.5300Why 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
K150094Device 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
884.5300Why 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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