(551 days)
Love Alchemy's Love Lotion is a 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 not for use with condoms.
Love Alchemy's Love Lotion is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity. Love Lotion ingredients are Shea Butter, Coconut Oil, Grapeseed Oil, Lavender Oil, Orange Peel Oil, Jasmine Oil, Sandalwood Oil, Patchouli Oil and Ylang-Ylag Oil. Device specifications are color, odor, appearance, viscosity, total aerobic microbial count, total yeast and mold count, absence of pathogenic microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
The provided document is a 510(k) summary for a personal lubricant, "Love Alchemy's Love Lotion," and therefore does not contain information related to an AI/ML medical device. As such, the requested details regarding acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set size are not applicable and cannot be extracted from this document.
The document discusses the substantial equivalence of the lubricant to a predicate device based on non-clinical performance testing.
§ 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.