Since 2000, the FDA has exempted 510(k) requirements for surgical apparel other than surgical gowns and surgical masks. At that time, the FDA intended for “surgical gowns” to mean any gown “intended for use during surgical procedures and/or for use to provide high level barrier protection,” while an isolation gown was a gown “intended to provide minimal or low levels of barrier protection.”
Since then, however, several terms have emerged to describe such gowns, according to the FDA.
To simplify things, the FDA’s draft guidance proposes that any gown that claims to provide ANSI/AMMI PB70 Level 3 or Level 4 protection (moderate or high level barrier protection) is a surgical gown, and it needs to demonstrate the barrier performance and requires premarket notification, according to AMMI.
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