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K-Y® Silicone is indicated for penile, vaginal and/or anal 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, polyisoprene, and polyurethane condoms.

K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532).

Intended 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. This product is not compatible with polyurethane condoms.

KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness. The subject device will be packaged as follows: - 12 mL Polyethylene terephthalate (PET) bottle - Polypropylene (PP) pump - Polypropylene (PP) snap-on cap - Outer carton The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

Durex Silicone is indicated for perile 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, polyisoprene, and polyurethane condoms.

Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.

K-Y® BRAND TOUCH® All-in-One Warming Caressing Crème and Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to lubricate and 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, polyisoprene, or polyurethane condoms.

K-Y® BRAND TOUCH® All-in-One Warming Caressing Creme and Personal Lubricant, is a nonsterile, anhydrous, fragranced, glycol-in-silicone emulsion that provides a warming sensation upon contact with ambient moisture on the skin. It is composed of a combination of lubricants and emollients, an antioxidant, a gelling agent, a thickener, a film former, a stabilizer, a surfactant, and a fragrance. The emulsion is off-white to beige in color with a slight hint of vanilla and/or floral scent. It has a viscosity, specific gravity, and lubricity typical for emulsions of this type. The product will be filled in printed black 3.0 ounce high density polyethylene (HDPE) heart shaped bottles, sealed with black pump closures, and packaged in printed cartons.

Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.

Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).

Durex Embrace Pleasure Gels, which includes the Warming Sensation Gel and Tingling Experience Gel, are intended 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 lubricants are compatible with natural rubber latex, synthetic polyisoprene and polyurethane condoms.

Durex Embrace Pleasure Gels are clear odorless slightly viscous liquids that are packaged together and consist of two different formulation is water-based with multisensate (Tingling Experience Gel) and the female formulation (Warming Sensation Gel) is Vanillyl Butyl Ether in Glycerine base. The female lubricant (Pink Bottle) offers a warming experience, and one for the male partner (Purple bottle) offers a tingling experience. Devices are supplied in 60 ml PETG pump bottles. Both lubricant bottles are covered with a shrink sleeve including graphics that also provides tamper evident protection. Bottles are then placed in clear trays, which are then shrink-wrapped and placed in printed cartons.

SPOROX® II has the same intended use as SPOROX®. SPOROX® II is intended to be used as a ready-to-use liquid chemical sterilant for the sterilization or high level disinfection of heat sensitive medical equipment for which alternative methods of terminal reprocessing are not suitable or available. SPOROX® II Sterilizing & Disinfecting Solution is a ready to use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. SPOROX II ® Sterilizing & Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. SPOROX II® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

SPOROX® II is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in SPOROX® II, exerts its germicide via a strong oxidation reaction with cellular components.

Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20℃ to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Sporox is a nominal 7.5% hydrogen peroxide solution, buffered with phosphoric acid. Hydrogen peroxide, the active ingredient in Sporox, ® exerts i s germicide via a strong oxidation reaction of cellular components.