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 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.
Condoms are regarded by the United States Food and Drug Administration (FDA) as “Class II medical devices”, this designation also includes pregnancy tests and powered wheelchairs believe it or not. Products in this category have to meet special labeling requirements and performance standards. For condoms, the FDA standards include systematic “water leak” tests to ensure that no fluid can leak out of the condoms. To meet FDA standards, all condoms sold in the US 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 to consumers.
There are lots of ways to test condoms that avoid ethical issues while adhering to high standards of uniformity. These kinds of tests are what all governments use. Some tests measure the durability of the entire condom, some measure only part of the condom, and some test for holes. Some of the more common tests involve testing empty condoms (or putting water in them).
This is a non-destructive test applied to all condoms. Each condom is tested to see if it blocks electricity. An intact condom should not allow electricity to pass through it.
The next tests are all destructive, a tested condom cannot be sold.
Used by the Food and Drug Administration, this test involves filling a condom with 10 ounces of water and looking for leaks.
(stretch test): This method involves slicing a band from the shaft of a condom and testing its stretch-ability
A method used by many European countries, Canada, and now the U.S., inflates the condom with air until it bursts; the maximum volume of air tolerated is used as the measure of strength.
Other tests are of the packaging (package integrity test, lubricant test) and a simulated aging test by warming the wrapped condom in an oven at 70° C.
Regardless of which specific test is used, condom testing involves taking a sample of several condoms from a batch and calculating the fraction that pass the test. The condoms tested are thus a sample (sampling model) of the others in the batch. In the US, a batch of condoms cannot be sold if 5 or more condoms per 1000 fail the test.
So, to sum it up, you can be relatively confident that any condom sold in the U.S. (and maintained under proper conditions) will survive the water test and airburst test and should have less than a 5% failure rate (on average)
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