(268 days)
pjur® Silicone Gel, pjur® Basic Personal Glide, pjur® Light, pjur® Med Premium Glide are personal lubricants, for genital area application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural latex, polyurethane, and polyisoprene condoms.
The pjur® family of silicone based lubricants are non-sterile, silicone-based personal lubricants. These over-the-counter products are formulated to be clear, non-irritating, non-greasy, and odorless. The pjur® family of silicone based lubricants contains neither a contraceptive nor a spermicide.
The provided text describes a 510(k) premarket notification for a family of silicone-based personal lubricants. It does not describe an AI device or a study proving its performance against acceptance criteria in the context of AI/medical imaging.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the provided document. The document pertains to the regulatory clearance of a physical consumer product (personal lubricants).
§ 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.