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510(k) Data Aggregation
K Number
K242712Device Name
LubriZenzs
Manufacturer
SK Zen LLC
Date Cleared
2025-06-04
(268 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LubriZenzs is a personal lubricant for vaginal and/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 lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
LubriZenzs is a non-sterile, water-based, over-the-counter personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. Its formulation consists of water, propanediol, cellulose gum, algin, 1,2-hexanediol, sodium hyaluronate, lactic acid, gluconolactone, Tremella fuciformis (mushroom) extract, caprylhydroxamic acid, sodium benzoate, calcium gluconate, sodium hydroxide, xylitylglucoside, anhydroxylitol, glycogen, xylitol, and glucose.
The Lubricant comes in a 100 mL white polypropylene plastic airless pump bottle, with a clear overcap. The lubricant has a shelf-life of 2 years.
Specifications:
- Appearance: Clear, flowable
- Color: Colorless
- Odor: Odorless
- pH: 4.5-5.0
- Viscosity: 10,000 – 25,000 cps
- Osmolality: 135 - 380 mOsm/kg (1:10 dilution)
- Total Microbial Count (TAMC): < 100 cfu/g
- Fungal/Yeast/Mold Limits (TYMC): < 10 cfu/g
- Absence of Pathogenic Organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Escherichia coli, Candida albicans): Absent
- Antimicrobial Effectiveness: Meets USP <51> criteria for category 2. Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days.
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K Number
K243107Device Name
Water Solubility Human Body Lubricant
Manufacturer
Dongguan Yanxuan Biotechnology Co., Ltd.
Date Cleared
2025-05-09
(221 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Water Solubility Human Body Lubricant is a personal lubricant for penile, anal 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
Water Solubility Human Body Lubricant is a clear, colorless, odorless and semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene, and is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal, 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 sold as an over-the-counter (OTC) product in 120 mL size provided in clear polyethylene terephthalate (PET) bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of Hyaluronic acid, Lubrajel CG, Lubrajel oil, Panthenol, Trimethyl glycine, Pentanediol, Hydroxyacetophenone, Ethylene glycol, Glycerol, Purified water.
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K Number
K250629Device Name
Sutil Rich Personal Lubricant
Manufacturer
Hathor Professional Skincare Ltd.
Date Cleared
2025-05-02
(60 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutil Rich Personal 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. The product is not compatible with polyurethane condoms.
Device Description
Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.
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K Number
K242958Device Name
Joylux Intimacy Gel (PG3100)
Manufacturer
Joylux, Inc
Date Cleared
2025-03-20
(176 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
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K Number
K241443Device Name
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)
Manufacturer
Hathor Professional Skincare Ltd.
Date Cleared
2025-01-21
(244 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant 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. The products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
Device Description
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are non-sterile, water-based personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are sold as over-the-counter (OTC) products in tube packaging made of low-density polythethylene (outer layer), ethylene vinyl alcohol copolymer (middle layer) and low-density polyethylene (inner layer), ranging from 0.34 fl oz to 8 fl oz, depending on formulation.
These products are composed of purified water, propanediol, oat beta glucan, hyaluronic acid, gluconolactone, sodium benzoate, steviol glycosides, and Nelumbo Nucifera (Lotus) Root water. Depending on the formulation, the flavored formulations contain natural vanilla 1.5X flavor extract, organic coconut flavor concentrate, or organic mint flavor concentrate.
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K Number
K242645Device Name
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
Manufacturer
Project Chemistry, Inc.
Date Cleared
2024-12-06
(94 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INA Moisturizing Intimate Water-Based 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, polyurethane, and polyisoprene condoms.
Device Description
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is a non-sterile, water-based, personal lubricant that is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device is for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication. INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant is sold as an over-the-counter (OTC) product in a 3 fl. oz./ 90 mL Polyethylene vinyl alcohol bottle with Polypropylene flip cap. The Tube will be packaged in an outer box. This product is composed of Deionized Water, Organic Certified Aloe Vera Gel, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Propanediol, Sclerotium Gum, Sodium Hyaluronate, Tremella Fuciformis Sporocarp Extract, Xanthan Gum, Lactic Acid, Red Alga Gel EC, Sodium Benzoate, Potassium Sorbate, Moringa Oleifera Seed Oil, Cariborg Sea Buckthorn Oil Refined.
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K Number
K240745Device Name
ID Free Personal Lubricant
Manufacturer
Westridge Laboratories, Inc.
Date Cleared
2024-09-27
(192 days)
Product Code
NUC, AST
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ID Free® Personal Lubricant is for or penile, anal 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 polyisoprenecondoms. This product is not compatible with polyurethane condoms.
Device Description
ID Free® Personal Lubricant is a personal lubricant, for penile, anal 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. The product is intended for over-the-counter use.
The device is a non-sterile water based personal lubricant with a clear, odorless formulation. The device is packaged in nonsterile 8.5 fl. oz/250 ml plastic/PET bottles with a screw-on cap and flip top closure, or in 0.14 fl. oz/4 ml foil sachets.
The device is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is not a contraceptive and does not contain a spermicide.
The device formulation consists of water, propanediol, hydroxyethyl cellulose, carbomer, PEG-45M, tetrahydroxypropyl ethylenediamine, EDTA, caprylhydroxamic acid, and sucralose.
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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?
Product Code :
NUC
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
K240081Device Name
Human Lubricant
Manufacturer
Jiangxi Wulinxiang Biological Technology Co., Ltd.
Date Cleared
2024-08-16
(218 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WLX & Bio Human Lubricant is a water based personal lubricant, for penile 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Device Description
WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).
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K Number
K234099Device Name
Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
Manufacturer
Select Labs, LLC
Date Cleared
2024-06-07
(164 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Product Code :
NUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Select Hybrid 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Select Pure Silicone Personal 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Device Description
The Select Hybrid Personal Lubricant and Select Pure Silicone Personal Lubricant are nonsterile, over the counter, personal lubricants. These devices are 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. Both lubricants are not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These lubricants are neither a contraceptive nor a spermicide.
The Select Hybrid Personal Lubricant formulation consists of distilled water, cyclopentasiloxane, dimethicone, dimethiconol, methylparaben, Cellosize™ hydroxyethyl cellulose PEG-10, and propylene glycol. The Select Pure Silicone Personal Lubricant formulation consists of cyclopentasiloxane, dimethicone, and dimethiconol.
Both subject devices are packaged in high density polyethylene bottles (2oz., 40z., 80z., 160z., 32 oz., 64oz., and 128 oz.) with low density polyethylene caps or polypropylene/polyethylene/stainless steel combination pumps. The bottle closure/pumps are covered with a heat shrink polyethylene terephthalate glycol sleeve film.
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