Condoms are classified as Class II

Condoms are classified as Class II Medical Devices. According to the Medical Device Amendments of 1976 of the FDA, the FDA is required to inspect each condom manufacturing plant at least once every two years. All electrical and mechanical equipment must be impeccably maintained. Condom-dipping machines are designed to operate continuously; if they remain idle, their mechanisms can get clogged and rust. During any downtime, partially cured compound cannot be left in the dip tank because it could contaminate future production.

All condoms sold in the U.S. must comply to specifications that were voluntarily developed by condom manufacturers and adopted by the FDA. Condom measurements can range from 5.8-7.8 inches (150-200 mm) in length, 1.8-2.1 inches (47-54 mm) in width, 0.001-0.003 inches (0.03-0.09 mm) in thickness (although most condoms range between 0.002 and 0.0024 inches), and the weight cannot exceed 0.07 ounces (2 grams). Additionally, physical characteristics must include a minimum tensile strength of 15,000 pounds psa and elongation before breakage of 625%.

The FDA reviews U.S. company records and spot checks batches for cracking, molding, drying, or sticking latex. The organization also tests every lot of imported condoms. Upon sampling, lots will not pass inspection if they reveal greater than 4% failure with respect to the above dimensions, 2.5% failure with respect to tensile strength and elongation, and 0.4% failure due to leakage.