It is important to recognize that latex condoms for men are a well-made medical device that laboratory studies have shown to provide an essentially impermeable barrier to particles the size of STD pathogens. FDA has oversight responsibility to ensure that condoms are manufactured properly, and manufacturers - in turn - follow quality system regulations, including design controls, to ensure that their products do what they are intended to do: protect against pregnancy and sexually transmitted diseases.
Thank you for contacting TheyFit.
Condoms are regulated medical devices and as such require regulatory approval for each country or region they are sold in. Currently TheyFit have clearance for sale in all 27 European countries, to nearly 500,000,000 people.
We are working hard on regulatory approval for sales into the US (approval is given by the FDA) and encourage US citizens to sign up here http://www.theyfit.co.uk/pages/country-availability-form to receive updates on the situation.
There are simply no similar products currently available in the United States – the E33 has a nominal width of 41mm and length of around 4.5” – the FDA rules on the other hand insist that all US condoms are at least 6.8” long and must have nominal width 47-57mm (until 2008 it was 50-54mm). In reality those condoms regularly available are at least 8” long with nominal width 49-56mm.
I am sorry for any confusion caused. I have cancelled your order, refunded your money and added you to our notification list to receive news of TheyFit’s US clearance which we hope will happen in 2013.
Kind Regards,
Joanne
TheyFit Customer Services
President Boris Yeltsin called Clinton with an emergency: "Our largest condom factory has exploded!" the Russian President cried; "my people's favorite form of birth control! This is a true disaster!"
"Boris, the American people would be happy to do anything within their power to help you," replied the President.
"I do need your help," said Yeltsin. "Could you possibly send 1,000,000 condoms ASAP to tide us over?"
"Why certainly! I'll get right on it!" said Clinton.
"Oh, and one more small favor, please?" said Yeltsin.
"Yes?"
"Could the condoms be red in color and at least 10" long and 4" in diameter?" said Yeltsin.
"No problem," replied the President and, with that, Clinton hung up and called the President of Trojan. "I need a favor....you've got to make 1,000,000 condoms right away and send them to Russia."
"Consider it done," said the President of Trojan.
"Great! Now listen, they have to be red in color, 10" long and 4" wide."
"Easily done. Anything else?"
"Yeah," said the President, "print 'MADE IN AMERICA, SIZE SMALL' on each one.
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