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510(k) Data Aggregation

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

    **Church **& Dwight Co

    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
    K240379
    Device Name
    TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2024-10-08

    (244 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is made of a styrene-isoprene-styrene copolymer sheath, which covers the penis with a fitted membrane, and a silicone lubricant applied directly to the exterior of the condom. The condom is straight-walled, smooth, and has a nipple end. The condom has a nominal length of 185 mm, a nominal flat width of 55 mm, a nominal thickness of 0.065 mm, and conforms to the requirements of ISO 23409:2011(E).
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    K Number
    K221906
    Device Name
    TROJAN Fire & Ice lubricated male natural rubber latex condom
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2022-09-28

    (90 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROJAN™ Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TROJAN™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.
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    K Number
    K221431
    Device Name
    TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2022-07-14

    (58 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a warming lubricant applied directly to the condom to create a perception of warming. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The TROJAN™ Her Pleasure Warming natural rubber latex condom with warming lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.
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    K Number
    K203818
    Device Name
    Replens Long-Lasting Vaginal Moisturizer
    Manufacturer
    Church & Dwight Co., Inc
    Date Cleared
    2021-06-11

    (164 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to 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
    Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant. The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.
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    K Number
    K193450
    Device Name
    Pre-Seed™ Fertility Lubricant
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2020-07-23

    (223 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pre-Seed™ 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. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Pre-Seed™ 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
    Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine. Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
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    K Number
    K180764
    Device Name
    TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
    Manufacturer
    Church & Dwight Co., Inc
    Date Cleared
    2018-08-01

    (131 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
    Device Description
    The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water). The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.
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    K Number
    K180104
    Device Name
    Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
    Manufacturer
    Church & Dwight Co., Inc
    Date Cleared
    2018-03-14

    (57 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane and has a silicone-based lubricant containing low levels of sensory ingredients applied directly to the condom to create a perception of warming, cooling, and/or tingling. The condom is a bulbous shaped condom with 11 rows of continuous ribs on the shaft and 9 rows of continuous ribs on the bulb. The Trojan™ Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat-width of 54 mm, measured 30 mm from the open end. The bulbous portion at the closed end of the condom has a flat-width of 65 mm.
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    K Number
    K171639
    Device Name
    Trojan Supra Lubricated Polyurethane Male Condom
    Manufacturer
    Church & Dwight Co., Inc.
    Date Cleared
    2017-08-01

    (60 days)

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

    **Church **& Dwight Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trojan Supra Lubricated Polyurethane Male Condom is intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections.
    Device Description
    The TROJAN SUPRA™ Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricated coating. The condom is a straight-walled, non-textured, nipple-end condom with a nominal length of 190 mm and a nominal flatwidth of 58 mm. This product has a 5-year shelf-life.
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    K Number
    K161915
    Device Name
    Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
    Manufacturer
    CHURCH & DWIGHT CO.,INC.
    Date Cleared
    2016-09-09

    (59 days)

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

    **CHURCH **& DWIGHT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trojan XOXO Intense Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Vera OE Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Trojan™ XOXO™ Intense Ribbed Natural Rubber Latex Male Condom with Silicone and Aloe Vera OE Lubricant [Trojan™ XOXO™ Intense Ribbed condom] is a natural rubber latex sheath, which completely covers the penis with a fitted membrane. A silicone base lubricant containing Aloe Vera OE is applied directly to the condom. The condom is a bulbous reservoir end shape and relies on ASTM D3492-08 Standard Specifications for Rubber Contraceptives (Male condom) and ISO 4074:2002 Natural Rubber Latex Condoms - Requirements and test methods. The condom has ribs on the shaft and bulb. The Trojan™ XOXO™ Intense Ribbed condom has a nominal length of 185 ± 10 mm, a nominal thickness 0.09 ± .01mm, nominal flat-width of 54 ± 2 mm measured 30 mm from the open end and 65±2 mm bulb flat width. The Trojan™ XOXO™ Intense Ribbed condom is individually packaged into a foil container. Multiple individually foiled condoms may be packaged in a carton.
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