(163 days)
Durex Play™ Tingling Lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
Durex Play™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.
The provided text is a 510(k) premarket notification summary for a medical device, Durex Play™ Tingling Lubricant. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, a study validating performance against such criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.
Therefore, I cannot provide the requested table and information based on the given input, as the document focuses on regulatory submission for substantial equivalence rather than a detailed performance study. The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often without requiring new clinical trials or detailed performance studies if equivalence can be established through design, materials, and intended use.
§ 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.