First polyurethane condom supplier in the world
UK is center of condom production in the history, the NO. 1 condom brand Durex come from there. So they also the first one to produce this new material condom. In 1994, London International Group introduced his first male polyurethane condom in the USA, after having received FDA 510k premarket approval by the Food and Drug Administration (FDA) in 1989. Prior to the commercial debut of this polyurethane male condom, its manufacturer had commissioned a series of slippage and breakage studies; these indicated consistently low clinical breakage rates of 0.3-2.1%.
Series of small-scale condom testing studies that compared this polyurethane condom and a latex control condom in 1991-1993, undertaken by the California Family Health Council (formerly known as the Los Angeles Regional Family Planning Council) in preparation for a contraceptive efficacy study, obtained breakage rate at 4-15% for the polyurethane condom and 1-2% for the latex male condoms, respectively. These small test studies, however, lacked sufficient power to produce statistically significant final results. In the following articles, we will report on a recent study specifically designed to overcome this limitation, one with sufficient power to detect an absolute difference of 2% or more between the clinical breakage rates of the two types material condoms.
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