The FDA is reminding manufacturers of surgical gowns that they need to submit a 510(k) application to commercially distribute their products.
The reminder comes in the form of draft guidance, issued June 30, explaining the premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns used in healthcare settings.
According to the agency, inconsistent terminology in the field has led to confusion over what constitutes a surgical gown, a Class II device subject to premarket notification. Other gowns used in nonsurgical situations in healthcare, such as isolation gowns, are exempt from this regulatory requirement.
The guidance highlights an American National Standards Institute and Association for the Advancement of Medical Instrumentation standard related to protective barriers, which describes four levels of barrier performance — Level 1 being the lowest level of protection and Level 4 the highest. As FDA spokeswoman Deborah Kotz tells IDDM, the definitions of the gowns detailed in the standard were not harmonized with those in a 2000 final rule from the FDA on surgical apparel.
The new draft guidance differentiates between Class I and II gowns, saying the former must be labeled as a gown other than a surgical gown and, if it has statements related to barrier protection, they are for minimal- or low-barrier protection. Class II surgical gowns must be labeled as such, have statements related to moderate- or high-level barrier protection and/or have statements that they are intended for use during surgical procedures.
Manufacturers that don’t have an existing clearance must submit an application to the FDA within 60 days of the final guidance’s publication. The agency has 75 days from publication to accept the application for review and gowns must have clearance within six months of publication.
Kotz says between 275 and 300 manufacturers are involved in gown production, packaging and distribution in the U.S. The FDA has no immediate plans to address other forms of personal protective equipment, she tells IDDM.