Search Results
Found 14 results
510(k) Data Aggregation
K Number
K241617Device Name
Durex Polyisoprene Condom
Manufacturer
RB Health (US) LLC
Date Cleared
2025-02-28
(268 days)
Product Code
MOL
Regulation Number
884.5300Why 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
Ask a Question
K Number
K230781Device Name
Belle Sensilube
Manufacturer
RB Health (US) LLC
Date Cleared
2023-06-20
(90 days)
Product Code
NUC
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K213892Device 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
884.5300Why 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.
Ask a Question
K Number
K220489Device Name
Durex Patronus CloseFit, Durex Patronus Regular
Manufacturer
RB Health (US) LLC
Date Cleared
2022-11-07
(258 days)
Product Code
HIS
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K222068Device Name
Durex Penck III Regular
Manufacturer
RB Health (US) LLC
Date Cleared
2022-10-12
(90 days)
Product Code
HIS
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K211152Device Name
Durex Condom with Benzocaine
Manufacturer
RB Health (US) LLC
Date Cleared
2022-05-11
(387 days)
Product Code
HIS
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K213647Device Name
Durex Patronus Wide
Manufacturer
RB Health (US) LLC
Date Cleared
2022-02-17
(90 days)
Product Code
HIS
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K211088Device Name
Grosz Play Feel
Manufacturer
RB Health (US) LLC
Date Cleared
2021-07-09
(88 days)
Product Code
NUC
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K200672Device Name
Durex Penck Standard, Durex Penck XL
Manufacturer
RB Health (US) LLC
Date Cleared
2020-11-06
(238 days)
Product Code
HIS
Regulation Number
884.5300Why 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.
Ask a Question
K Number
K201186Device Name
KY Grosz Jelly
Manufacturer
RB Health (US) LLC
Date Cleared
2020-07-30
(90 days)
Product Code
NUC
Regulation Number
884.5300Why 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.
Ask a Question
Page 1 of 2