FDA regulates surgical gowns and surgical isolation gowns as Class II devices that need 510(k) clearance; non-surgical isolation gowns are Class I and exempt from premarket review. The ANSI/AAMI PB70 standard sorts protective apparel into four barrier levels, from Level 1 (minimal risk) to Level 4 (high risk), and for isolation gowns every area except the bindings, cuffs and hems counts as a critical zone. FDA’s advice is to look for labeling that states the gown’s intended use and level of protection; the level a task calls for is your facility’s decision.
Under Enhanced Barrier Precautions, nursing-home staff wear a gown and gloves together for high-contact care of residents who meet CDC’s criteria.
Each listing shows the PB70 level, material, cuff (knit, elastic or thumb loop), closure, sizes, sterile or non-sterile, and gowns per case, as the manufacturer states them.
We carry isolation gowns from Halyard and Medline.