FDA Approved Condoms? What does it mean?

Condoms are regarded by the Food and Drug Administration (FDA) as “Class II medical devices”, which in same control level in all the countries. Products in this category have to meet special labeling requirements and performance standards. As for the condoms, the FDA standards include systematic “water leak” tests to ensure that no fluid can leak out of the condoms. To meet these FDA standards, all condoms sold in the market must have at least a 99.6% test score (rating) This basically means that 996 out of 1,000 condoms, on average, must pass this test. FDA-approved condoms must be at least 99.6% effective in laboratory tests to be available sold to consumers.

The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs and medical appliances. In the simplest terms, “FDA approval” means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item's planned use. The FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by condom manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.

Source: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm