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FDA Issues Draft Guidance on Gowns For Use in Health Care Settings

Today, the U.S. Food and Drug Administration released a draft guidance document,"Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings."
The purpose of this guidance 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.
Gowns are considered a Class II device under 21 CFR 878.4040(b)(1) and are subject to premarket notification if it:
• is labeled as such; (e.g., “surgical gown” or “surgical isolation gown”)
• is described as such in its labeling; (e.g., this gown is suitable as a surgical gown”)
• has statements relating to moderate or high level barrier protection (e.g. ANSI/AAMI PB70 Level 3 or 4 barrier protection claims); and/or
• has statements that it is intended for use during sterile procedures (e.g. distributed in sterile package).
Gowns are considered Class I, exempt from premarket notification under 21 CFR 878.4040(b)(2), subject to the limitations in 21 CFR 878.9, as surgical apparel other than surgical gowns and surgical masks if it:
• is labeled as a gown other than a surgical gown (e.g., isolation gown); 
• is not described in its labeling as a surgical gown; and
• has statements relating to barrier protection claims, such statements are for only minimal or low barrier claims to show that its intended use is as a nonsurgical gown.
For gowns that are considered a Class II device under 21 CFR 878.4040(b)(1) and subject to premarket notification, manufacturers should include the following in the 510(k):
1. Evidence that the gown complies with the claimed barrier performance criteria of the currently FDA-recognized version of ANSI/AAMI PB70, or equivalent standard. ANSI/AAMI PB70 establishes physical performance and documentation requirements for gowns and their materials. 
2. Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. Barrier performance testing should be completed on the final, finished, pre-shipment gown, or at the end of the stated shelf life of the gown, as applicable, if the gown is reusable. 
3. Representative engineering drawing(s), schematics, illustrations and/or figures of the gown that are clear, legible, labeled with the barrier protection levels of the gown, and include dimensions and the location of the critical and non-critical zones.
4. Sample labeling that clearly identifies the level of liquid barrier protection per ANSI/AAMI PB70.
5. Sample labeling that include the direction(s) for use and indication(s) for use.

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