Tag Archives: Surgical Gown

Surgical Gowns

What is Surgical Gown? A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer … Continue reading

Documentation, Gown

ANSI/AAMI PB70 Standard Recognized by the FDA

Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown. The performance of gowns is tested using consensus standards: American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical … Continue reading

Documentation, Gown