Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
/ Subpart F - General Hospital and Personal Use Therapeutic Devices / § 880.5180 Burn sheet.
§ 880.5180 Burn sheet.
(a) Identification. A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.