(87 days)
A latex condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.
Rubber Latex Condom (Magnesium and Calcium Carbonate Finishing agents
This document is an FDA 510(k) clearance letter for Durex® Latex Condoms, not a study evaluating acceptance criteria for a medical device. Therefore, I cannot extract the requested information as it is not present in the provided text.
The document indicates that the device (Durex® Latex Condoms) was found substantially equivalent to devices marketed prior to May 28, 1976. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device. This process does not typically involve the detailed acceptance criteria and study data often found in premarket approval (PMA) applications or clinical trials.
The text provided in the prompt is an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. Therefore, it does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The primary information conveyed is the FDA's regulatory decision regarding market clearance for the Durex® Latex Condoms based on substantial equivalence.
§ 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.