What is the difference between an Antifungal claim and an Antimicrobial claim for InterDry Ag?
A. InterDry Ag has an Antimicrobial claim. An antimicrobial claim actually covers both fungal and bacterial claims. Given this we can talk about InterDry Ags effectiveness against both categories. Explicitly called out in the 510(k) filing were the organisms C. albicans (yeast), the following gram-positive, gram- negative bacteria, P. aeruginosa, S. epidermidis, and S. aureus. Please remember however that we must talk about the antimicrobial activity IN THE TEXTILE as this is a Class I medical device. This wording is similar to Contreet.
