(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 UltraGel 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, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is 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 UltraGel is a personal lubricant for over-the-counter (OTC) use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KY Grosz UltraGel, structured to answer your specific questions.
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | ||
| Appearance | Colorless to slightly yellow, clear to translucent liquid | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this, though no direct measured value is given in summary) |
| Odor | No objectionable odor | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Viscosity | 100-950 cPs | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Osmolality | 780-1180 mOsm/kg | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| pH | 3.5 - 4.5 | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Microbiological Purity | ||
| 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.