(336 days)
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Good lubrications may be used with condoms.
Good Lubrications Personal Lubricant
The provided text is a 510(k) Premarket Notification from the FDA for a device named "Good Lubrications." This document does not describe acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.
Instead, it is a letter from the FDA to BioFilm, Inc. stating that their device has been found substantially equivalent to legally marketed predicate devices. This means the device can be marketed in the US.
Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies from this document. The document is an administrative approval of a medical device based on substantial equivalence, not a medical device performance study report.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.