(134 days)
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are personal lubricants 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. They are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.
Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, and Grosz Play Strawberry are water-based personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. The products are not compatible with polyurethane condoms. They are for over-the-counter (OTC) use. The formula consists of water, propylene glycol. xanthan gum, carbomer, benzoic acid, sodium hydroxide, sodium saccharin and flavor. Grosz Play Aloe, Grosz Play Ylang, and Grosz Play Guarana are packaged in a 200 mL polyethylene terephthalate (PET) bottle fitted with a polypropylene (PP) cap. Grosz Play Cherry and Grosz Play Strawberry are packaged in a 50 mL high density polyethylene (HDPE) bottle fitted with a polypropylene (PP) cap. The bottle and cap feature a tamper evident shrink seal label. The individual bottles may be packaged in an outer cardboard carton.
The document provided describes the acceptance criteria and performance of personal lubricants. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a personal lubricant, and the acceptance criteria are based on various physical, chemical, and microbiological specifications, as well as biocompatibility and condom compatibility. The performance data is reported as meeting these specifications.
| Specification | Acceptance Criteria | Reported Device Performance (all variants unless specified) |
|---|---|---|
| Physical/Chemical Specifications | ||
| Appearance | Clear to slightly translucent, colourless to slightly yellow colour homogeneous gel and free from particulate matter (for Aloe, Ylang, Guarana); Colorless, transparent gel, free from lumps and particulate matter (for Cherry, Strawberry) | Meets criteria |
| Odor | No objectional odor (for Aloe, Ylang, Guarana); Characteristic of cherry (for Cherry); Characteristic of strawberry (for Strawberry) | Meets criteria |
| Viscosity (cps) | 3,300 - 10,000 (for Aloe, Ylang, Guarana); 3,400 - 10,000 (for Cherry, Strawberry) | Meets criteria |
| Osmolality (mOsm/kg) | 695 - 1,095 (Aloe); 720 - 1,120 (Ylang); 710 - 1,110 (Guarana); 683-1,083 (Cherry); 742 - 1,143 (Strawberry) | Meets criteria |
| Benzoic Acid | 0.15-0.22 %w/w | Meets criteria |
| pH at 25°C | 3.5 - 4.5 | Meets criteria |
| Microbiological Specifications | ||
| 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.