It is a Class III medical device with medicinal substance added. It will be marketed and sold just like any other condom according to the website. I guess this is 
actually a good thing in promoting the use of condoms and at the same time having a little added benefit? From what I am reading here this appears to be a topical solution that pretty much does the same thing that an ED pill would do but I would guess the strength of the drug being this is sold over the counter would not be as strong as taking a prescribed medication. Both increase blood flow. They have patents on the product and the next step it appears 
is to seek approval in the US.
“CSD500, our Condom Safety Device is a condom developed for use by healthy men. The product incorporates an erectogenic compound to help men maintain a firmer erection during intercourse whilst wearing a condom. The gel is to be licensed under the trademarked brand name of Zanifil®.
By applying the CSD500 condom, a pharmacological dose contained within the teat of the condom will be delivered to the penis. This has been clinically proven to increase local blood flow within the penis which in turn leads to increased firmness, increased penile size and longer duration of an erection.”
The product was tested in a double blind clinical study and obviously there were some positive results since we now have a new type of condom out there. Just as in any other disclosure, you need to be “healthy” to use the new condom. BD
LONDON (Reuters) – A British medical company has had its erection-enhancing condom recommended for European approval.
Futura Medical said its CSD500 condom -- licensed to pharmaceutical firm Reckitt Benckiser for sale under its Durex brand has gel in its tip that dilates the arteries and increases blood flow to the penis, resulting in a firmer and bigger erection.
Futura said on Monday products usually took about a month to receive CE mark certification after recommendation. The mark would enable the condom to be sold in 29 European territories and a number of other non-European countries.
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