Tag Archives: Class II MEdical Device

Surgical Isolation Gowns

What is Surgical Isolation Gowns Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns.  Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  As … Continue reading

Documentation, 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