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510(k) Data Aggregation

    K Number
    K242712
    Device Name
    LubriZenzs
    Manufacturer
    SK Zen LLC
    Date Cleared
    2025-06-04

    (268 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    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
    K243107
    Device Name
    Water Solubility Human Body Lubricant
    Manufacturer
    Dongguan Yanxuan Biotechnology Co., Ltd.
    Date Cleared
    2025-05-09

    (221 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    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
    K250629
    Device Name
    Sutil Rich Personal Lubricant
    Manufacturer
    Hathor Professional Skincare Ltd.
    Date Cleared
    2025-05-02

    (60 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    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
    K243967
    Device Name
    ONE Nitrile Condom
    Manufacturer
    Global Protection Corp.
    Date Cleared
    2025-04-08

    (106 days)

    Product Code
    MOL
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).
    Device Description
    Not Found
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    K Number
    K242958
    Device Name
    Joylux Intimacy Gel (PG3100)
    Manufacturer
    Joylux, Inc
    Date Cleared
    2025-03-20

    (176 days)

    Product Code
    NUC
    Regulation Number
    884.5300
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    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
    K243421
    Device Name
    Lelo Hex Lubricated Natural Rubber Latex Condom
    Manufacturer
    Lelo Inc.
    Date Cleared
    2025-03-07

    (123 days)

    Product Code
    HIS
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). It is a straight walled textured condom with a nipple end and made of natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. It has a nominal length of 190 ± 10 mm, nominal width of 54 ± 2 mm and nominal thickness of 0.06 ± 0.01 mm. Lelo Hex Lubricated Natural Rubber Latex Condom is packaged in individually sealed flexible laminate foils which is then packaged into an outer consumer cardboard carton. The Lelo Hex Lubricated Natural Rubber Latex Condom is intended for over-the-counter (OTC) use. These condoms conform with FDA-recognized standards ASTM D3492-16 and ISO 4074:2015.
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    K Number
    K241617
    Device Name
    Durex Polyisoprene Condom
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2025-02-28

    (268 days)

    Product Code
    MOL
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Polyisoprene Condom is used for contraception and for prophylactic purposes (to help regnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Not Found
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    K Number
    K243640
    Device Name
    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2025-02-21

    (88 days)

    Product Code
    HIS
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Trojan™ Ultra Ribbed Ecstasy latex condom with silicone lubricant (Trojan™ Ultra Ribbed Ecstasy) is made of a natural rubber latex sheath, which covers the penis with a fitted membrane. A silicone-based lubricant is applied directly to the condom during packaging. The condom is a bulbous shaped condom with 7 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The condom meets the specifications of ASTM D3492-16. The condom has a nominal length of 200 mm, a nominal thickness of 0.095 mm, nominal flat widths of 53 mm measured 30 mm from the open end and 71 mm at the bulbous, closed end, and 800 mg of silicone lubricant per condom. The condoms are packaged in individually sealed laminate (plastic inner layer, foil middle layer, and cellophane outer layer). The foils are packaged in an outer consumer cardboard carton.
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    K Number
    K243584
    Device Name
    0.04 ZERO ZERO FOUR Male Latex Condom
    Manufacturer
    Okamoto USA, Inc.
    Date Cleared
    2025-02-18

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.
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    K Number
    K241443
    Device 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
    884.5300
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    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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