Search Results

Ask a specific question about this device

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