[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5180]

[Page 414-415]
 
                        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,

[[Page 415]]

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 Sec. 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 
1994; 66 FR 38804, July 25, 2001]