FDA authorizes production of non-sterile hoods and togas

Stryker closely coordinated with the FDA to fast track clearance of a non-sterile version of its standard surgical hoods and togas and increased production by 40%, so that customers can receive these critical PPE items significantly faster. This non-sterile product can be used in healthcare environments outside of the operating room. The Flyte Personal Protection System, introduced in 2008, provides industry-leading protection that helps safeguard against viral penetration, exposure to infectious bodily fluids and transfer of microorganisms or particulate matter.

Stryker’s PPE products are not cleared as respiratory protective products. U.S. Centers for Disease Control and Prevention (CDC) guidance for respiratory protection directs the use of an N95 or higher rated mask for staff performing Aerosol Generating Procedures, Coronavirus Disease 2019 (COVID-19) | CDC. Healthcare personnel should adhere to Standard, Contact, and Airborne Precautions, including the use of eye protection (e.g., goggles). N95 respirators and goggles can be used under any of Stryker’s togas or hoods.

For more information about non-sterile hoods and togas contact your Orthopaedics Instruments sales rep or customer service:
inst.stryker.cs@stryker.com