(88 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Grosz Play Feel" personal lubricant. This document details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Grosz Play Feel personal lubricant are primarily derived from its device specifications and performance testing. The reported device performance is indicated by the results of these tests.
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Specifications (Table 1) | (Implied to meet these specifications as per the submission) | |
| Appearance | Viscous, clear gel | Viscous, clear gel |
| Odor | Odorless | Odorless |
| Viscosity | 3,400 - 10,000 cPs | Within the range of 3,400 - 10,000 cPs |
| pH | 3.5 - 4.5 | Within the range of 3.5 - 4.5 |
| Osmolality | 663 - 1,063 mOsm/kg | Within the range of 663 - 1,063 mOsm/kg |
| 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.