Antimicrobial wound dressings is consider a combination product, it is mainly used to cover partial and full-thickness wounds the wounds and it also help to reduce the risk of infection. I think it will be consider as CDRH and it does required RFD because it delivers a drug and 510(k)only because it is consider as class 1. And Bio-compatibility tests has to be done as required by ISO 10993.
[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=878.4018