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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    RB Health (US) LLC

    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
    K230781
    Device Name
    Belle Sensilube
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2023-06-20

    (90 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Belle Sensilube is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Belle Sensilube is compatible with natural rubber latex and polyisoprene condoms. Belle Sensilube is not compatible with polyurethane condoms.
    Device Description
    Belle Sensilube is a water-based personal lubricant for over-the-counter use. The subject device is a non-sterile liquid preparation containing water, propylene qlycol, hyroxyethylcellulose, polyacrylamide anionic, lactic acid and potassium lactate, and benzoic acid. The subject device will be packaged in a 40 mL high-density polyethylene bottle fitted with a polypropylene cap. The lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
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    K Number
    K213892
    Device Name
    Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2023-03-07

    (448 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grosz Warming Liquid is intended for penile, vaginal and/or anal application 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. Grosz Play Tingling is intended for penile, vaginal and/or anal application 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. Grosz KY Yours & Mine is intended for penile, vaginal and/or anal application to mosturize 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
    Grosz Warming Liquid is a non-sterile, silicone-based personal lubricant compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of Dimethicone and Sensate. Grosz Warming Liquid is packaged in a 30 mL high density polyethylene bottle (HDPE) mono layer and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Warming Liquid is a personal lubricant for over-the-counter (OTC) use. Grosz Play Tingling is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene Glycol, Carbomer, Xanthan Gum, Sensate, Benzoic Acid, Sodium Saccharin, and Sodium Hydroxide. Grosz Play Tingling is packaged in a 50 mL HDPE bottle and topped with a polypropylene cap. The bottle is then packaged in a carton. Grosz Play Tingling is a personal lubricant for OTC use. Grosz KY Yours & Mine are two personal lubricants with the same formulations and specifications as Grosz Warming Liquid and Grosz Play Tingling, respectively, packaged together and compatible with natural rubber latex and polyisoprene condoms. Grosz KY Yours & Mine is not compatible with polyurethane condoms when used as intended. Grosz KY Yours and Grosz KY Mine are individual lubricants separately packaged in a 44 mL polyethylene terephthalate bottles and topped with a polypropylene cap and packaged together in a carton. Grosz KY Yours & Mine are for OTC use.
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    K Number
    K220489
    Device Name
    Durex Patronus CloseFit, Durex Patronus Regular
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2022-11-07

    (258 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Patronus CloseFit and Durex Patronus Regular condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Durex Patronus CloseFit and Durex Patronus Regular are natural rubber latex-based condoms indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). Durex Patronus CloseFit and Durex Patronus Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Patronus CloseFit and Durex Patronus Regular have a nominal length of 190 mm and 195 mm, width of 52.5 mm and 56 mm, and thickness of 52 microns and 54 microns, respectively. The condoms are available in regular and extra lubricant varieties with 400 mg and 480 mg silicone lubricant, respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus CloseFit and Durex Patronus Regular condoms are 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
    K222068
    Device Name
    Durex Penck III Regular
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2022-10-12

    (90 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Durex Penck III Regular are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Penck III Regular are made of a non-colored natural rubber latex with silicone lubricant and are taper shaft, teat ended smooth shaped condoms. Durex Penck III Regular have a nominal length of 195 mm, width of 56 mm, and thickness of 48 um and are provided in Regular and Extra Lubricant varieties with 400 mg and 480 mg silicone lubricant respectively. The condoms are packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils are packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Penck III Regular condoms are 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
    K211152
    Device Name
    Durex Condom with Benzocaine
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2022-05-11

    (387 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Condom with Benzocaine is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    The Durex Condom with Benzocaine is a natural rubber latex-based condom used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). This is a textured condom with a silicone-based lubricant. Durex Condom with Benzocaine has a nominal length of 195 mm and width of 56 mm with a thickness of 65 um. The Durex Condom with Benzocaine is packaged with 480 mg of silicone lubricant. In addition, the Benzocaine male genital desensitizer paste on the condom helps in temporarily prolonging the time until ejaculation. This condom is a surface device that comes into contact with skin and mucosal membranes. Durex Condom with Benzocaine is packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils come packaged in an outer consumer cardboard carton. The Durex Condom with Benzocaine 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
    K213647
    Device Name
    Durex Patronus Wide
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2022-02-17

    (90 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Durex Patronus Wide condoms are used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Durex Patronus Wide are natural rubber latex-based condoms that completely cover the penis with a closely fitted membrane. Durex Patronus Wide is made of a non-colored natural rubber latex with silicone lubricant and is a taper shaft, teat ended smooth shaped condom. Durex Patronus Wide has a nominal length of 200 mm, width of 60 mm, and thickness of 62 um. It will be packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. The number of condoms in the carton may vary. Durex Patronus Wide condoms are 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
    K211088
    Device Name
    Grosz Play Feel
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2021-07-09

    (88 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grosz Play Feel is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Grosz Play Feel is compatible with natural rubber latex and polyisoprene condoms. Grosz Play Feel is not compatible with polyurethane condoms.
    Device Description
    Grosz Play Feel is a personal lubricant that is non-sterile, water-based, 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, Propylene Glycol, Xanthan Gum, Carbomer, Benzoic Acid, and Sodium Hydroxide. Grosz Play feel is packaged in 50 mL bottles composed of High Density Polyethylene (HDPE) and fitted with a Polypropylene (PP) cap. The bottle is packaged in an outer cardboard carton. Grosz Play Feel is a personal lubricant for over-the-counter (OTC) use.
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    K Number
    K200672
    Device Name
    Durex Penck Standard, Durex Penck XL
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2020-11-06

    (238 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Durex Penck Standard Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). The Durex Penck XL Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
    Device Description
    Durex Penck Standard and Durex Penck XL are natural rubber latex condoms that completely cover the penis with a closely fitted membrane. They are intended to be used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). These are straight-walled, parallel sided, teat ended, smooth, and non-colored condoms with a silicone-based lubricant. Durex Penck Standard has a nominal length of 190 mm and width of 54 mm with a thickness of 48 microns. Durex Penck XL has a nominal length of 190 mm and width of 57 mm with a thickness of 50 microns. Durex Penck Standard and Durex Penck XL will be packaged in individually sealed flexible laminate foils made of polyethylene terephthalate, polyethylene, and aluminum. The foils will come packaged in an outer consumer cardboard carton. Durex Penck Standard and Durex Penck XL condoms are 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
    K201186
    Device Name
    KY Grosz Jelly
    Manufacturer
    RB Health (US) LLC
    Date Cleared
    2020-07-30

    (90 days)

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

    RB Health (US) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for penile, vaginal and/or anal application 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
    K Y Grosz Jelly is a water-based personal lubricant intended for penile, vaginal and/or anal application 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, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene glycol, Hydroxyethylcellulose, Benzoic acid, Carbomer, Sodium hydroxide. KY Grosz Jelly may be packaged in 2 oz (57g) and 4 oz (113g) tubes composed of high-density polyethylene (HDPE) and linear low-density polyethylene (LLDPE), sealed with foil and fitted with a polypropylene (PP) cap. The individual tubes may be packaged in an outer cardboard carton. KY Grosz Jelly is a personal lubricant for over-the-counter (OTC) use.
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