(77 days)
This Device is A latex Condom: designed to Prevent PREGNANCY & help reduce the Risk. OF TRANSMISSION TO sexually transmitted diseases.
latex Condom
This document is a 510(k) clearance letter from the FDA for two brands of condoms: Trustex® and Impulse® Mint Flavored Condoms in Green Color. As such, it does not contain the information requested about acceptance criteria and a study proving a device meets them.
The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed. It discusses regulatory compliance, labeling requirements (including expiration dating), and general responsibilities under the Federal Food, Drug, and Cosmetic Act.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any study.
- Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot provide the requested information from this document.
§ 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.