FDA Sets Deadline for Surgical Gown Manufacturers to Submit a 510(k)

January 22, 2016

Manufacturers of certain surgical gowns must file a 510(k) early next month, with performance testing data to support liquid barrier claims, according to FDA guidance.

A gown that is not intended for use as a surgical gown is a Class I exempt device that is not subject to premarket notification requirements. However, a gown that is intended for use as a “surgical gown” is a Class II device subject to premarket notification, the final guidance says.

Class I gowns must be labeled as a gown other than a surgical gown. Further, 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 planning to market Class II gowns should submit a 510(k) by Feb. 7, have the submission accepted by Feb. 22 and obtain clearance by June 6.

The final guidance is largely similar to draft guidance issued last summer (IDDM, July 2, 2015). Several comments submitted during the consultation period raised concerns over the Feb. 7 deadline, but the FDA didn’t budge.

“We continue to believe this timeframe for submission is appropriate since submitters should already have conducted the testing to support their particular liquid barrier claims,” the FDA says.

Read the final guidance here: www.fdanews.com/01-16-FDA-Gowns.pdf. — Jonathon Shacat