(185 days)
Personal Lubricant is a water based personal lubricant, 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.
Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles.
This document is a 510(k) Premarket Notification for a Personal Lubricant, not an AI/ML medical device. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document.
The document discusses the substantial equivalence of the Personal Lubricant to a predicate device based on:
- Indications for Use: Same as predicate.
- Technological Characteristics: Similarities and differences in formulation, appearance, odor, viscosity, pH, and osmolality are compared.
- Non-Clinical Performance Testing:
- Biocompatibility: Tested according to ISO 10993 standards.
- Shelf-Life: Demonstrated to maintain specifications for 3 years.
- Condom Compatibility: Tested according to ASTM D7661-10(R) 2017 for compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.
The document does not describe an AI/ML device or its performance criteria.
§ 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.