[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4014]

[Page 381]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 878.4014  Nonresorbable gauze/sponge for external use.


    (a) Identification. A nonresorbable gauze/sponge for external use is 
a sterile or nonsterile device intended for medical purposes, such as to 
be placed directly on a patient's wound to absorb exudate. It consists 
of a strip, piece, or pad made from open woven or nonwoven mesh cotton 
cellulose or a simple chemical derivative of cellulose. This 
classification does not include a nonresorbable gauze/sponge for 
external use that contains added drugs such as antimicrobial agents, 
added biologics such as growth factors, or is composed of materials 
derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in part 807, subpart E of 
this chapter subject to the limitations in Sec. 878.9.

[64 FR 53929, Oct. 5, 1999]