(172 days)
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.
KY Grosz Liquid is a 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, PEG-400, Propylene glycol, Xanthan Gum, Carbomer, Benzoic acid, Sodium saccharin, and Sodium hydroxide. KY Grosz Liquid may be packaged in 1.5 fl. oz. (44 mL) or 4.5 fl. oz. (133 mL) bottles composed of high density polyethylene (HDPE), sealed and fitted with a polypropylene (PP) cap. The individual bottles are packaged in an outer cardboard carton. KY Grosz Liquid is a personal lubricant for over-the-counter (OTC) use.
This document describes the premarket notification (510(k)) for the KY Grosz Liquid, a personal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness in comparison to a predicate device, KY Banksy Aloe.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance (KY Grosz Liquid) |
|---|---|---|
| Appearance | Clear to translucent | Clear to translucent |
| Odor | No objectionable odor | No objectionable odor |
| Viscosity | 200-1200 cPs | (Not explicitly stated if within range, but implied satisfactory) |
| Osmolality | 690-1090 mOsm/kg | (Not explicitly stated if within range, but implied satisfactory) |
| pH | 3.5 - 4.5 | (Not explicitly stated if within range, but implied satisfactory) |
| Total Yeast and Mold Count (TYMC) |
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.