[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5180]

[Page 382]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63011, Dec. 7, 
1994]