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This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

The document discusses:

• The trade name of the device and its classification.
• The regulatory framework for medical devices.
• The intended use of the condom.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any study.
3. Details about experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Training set sample sizes or ground truth establishment for a training set.

Therefore, I cannot answer your request based on the provided input.

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THESE DIFFERENT TYPES (NATURAL ORDINARY, NATURAL RIBBED, NATURAL DOTTED, AND NATURAL CONTOURED) OF NATURAL LATEX RUBBER CONDON (WITH NONOXYNOL-9) ARE USED FOR CONTRACEPTION AND FOR PROPHYLACTIC PURPOSES (TO PREVENT PREGNANCY AND THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD'S).

Natural Ordinary, Natural Ribbed, Natural Dotted and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9)

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the Natural Ordinary, Natural Ribbed, Natural Dotted, and Natural Contoured (Multiple-Brand Male Latex Condom, Lubricated with Nonoxynol-9).

The document is a 510(k) substantial equivalence letter from the FDA, addressing a correction to a previous letter and outlining regulatory requirements for the device. While it mentions the need for expiration dating supported by test data according to 21 CFR 801.435, it explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA."

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device