Regulatory Focus™ > News Articles > FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

Posted 29 June 2015 | By Alexander Gaffney, RAC

FDA to Strengthen Definitional Standards for Surgical Gowns Under New Guidance

It is an iconic image replicated during almost every single infectious disease outbreak in the last century: men and women clad head to toe in surgical gowns and surgical masks, tending to the sick or working to disinfect contaminated areas. But iconic or not, the US Food and Drug Administration (FDA) has a more pressing concern: Are the gowns effective at protecting their users from the spread of infection?


The question is the focus of a new draft guidance document issued by FDA, Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.

Under 21 CFR 878.4040, surgical apparel is defined as:

"devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded."

As FDA explains in its new draft guidance document, not all surgical protective equipment is regulated equally.

Under 21 CFR 878.4040(b)(1), surgical gowns and surgical masks are Class II medical devices and require the submission of a 510(k) application and compliance with both general and special controls established by FDA under 21 CFR 878.4040(b).

However, not all surgical apparel is regulated as Class II devices. With the exception of surgical gowns and masks, most surgical apparel is regulated as Class I medical devices (21 CFR 878.4040(b)(2)). Class I products are exempt from premarket submissions or review, but must comply with general controls established by FDA.

Splitting Hairs

As FDA has previously noted, the performance of surgical gowns, and in particular surgical isolation gowns, is critical. If you have reason to wear a surgical gown in the first place, the last thing you want to worry about is whether liquid splatter containing an infectious microorganism will seep through and come into contact with your skin.

The problem, as FDA explains in the guidance, is that definitional confusion currently exists in the marketplace. For example, some standards-setting bodies use the term "isolation gown" to describe what FDA calls "surgical gowns." That's potentially problematic because FDA considers gowns claiming to provide higher levels of barrier protection "to be higher-risk devices than those that claim minimal or low levels of barrier protection."

If inconsistent definitions are used, companies might believe they are exempt from providing the required performance evidence, FDA said. "The purpose of this guidance, therefore, is to clarify and describe the premarket regulatory requirements pertaining to gowns regulated under 21 CFR 878.4040 and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings," FDA added.

The Guidance

FDA's guidance relies upon an existing standard maintained by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) known as ANSI/AAMI PB70. The PB70 standard described four levels of protection, with Level 1 protection offering a "minimal" amount of barrier protection, and Level 4 offering "high" barrier protection.

FDA says it considers Levels 1 and 2 to collectively offer "minimal or low" barrier protection, and Levels 3 and 4 to offer "moderate or high" barrier protection.

As FDA's guidance document goes on to explain, the claims made by a manufacturer about its surgical apparel (under 21 CFR 878.4040(b)(2)) will determine how it is regulated by FDA.

A gown (not a surgical gown) which is labeled with statements that it is intended to provide minimal or low barrier protection may be regulated as a Class I device exempt from premarket review.

However, if that same product is labeled as a surgical gown, claims to provide "moderate or high level barrier protection," or is intended for use during sterile procedures, it will be regulated as a Class II device and be subject to the 510(k) process and special controls established by FDA.

If a 510(k) is required of a surgical gown or related device, FDA says it must meet the PB70 standard and include performance test data intended to demonstrate barrier efficacy.

Under the new policy, existing products already on the market but requiring a 510(k) will be granted temporary leniency, FDA said.

Comments on the guidance document are due to FDA by the end of August 2015.


Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (FR)


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