Why condoms 99.6% percent effective in preventing pregnancy and STIs?

Condoms, considered as “Class II medical devices,” by the Food and Drug Administration (FDA) along with pregnancy tests and powered wheelchairs, meet special labeling requirements and performance standards. The FDA standards for condoms include a systematic “water leak” to ensure no fluid can leak out of the condoms with a minimum of 996 out of 1,000 having to pass the test. This is why FDA-approved condoms usually say they must be at least “99.6 percent effective.” These condoms are considered to be quite effective in preventing pregnancy and sexually transmitted infections (STIs).

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