FDA approved condoms manufacturer list

Each country has their own FDA or MOH department to regulate condom products, such as if you want to enter into USA market, you has to got FDA 510K, Or you can’t get through into USA market, USA is the world’s top tough market for condom’s registration, and we already successfully registered at more than 100 countries’ FDA, So we can enter into these market easily.

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. 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 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 their test. FDA-approved condoms must be at least 99.6% effective in laboratory tests to be available distribute to all consumers.

Condoms currently on the market in the US and elsewhere have been evaluated and approved based on clinical data from vaginal sex, not anal sex. ONE brand condom had got USA first anal use condom from FDA.

Welcome contact us if you plan buy own brand FDA approved condom,we are pleasure to custom work for you. Email: sales@OEMcondom.com or OEMcondom@gmail.com