[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: 21CFR878.4022]

[Page 398-399]
 
                        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. 878.4022  Hydrogel wound dressing and burn dressing.

    (a) Identification. A hydrogel wound dressing is a sterile or non-
sterile device intended to cover a wound, to absorb wound exudate, to 
control bleeding or fluid loss, and to protect against abrasion, 
friction, desiccation, and contamination. It consists of a nonresorbable 
matrix made of hydrophilic polymers or other material in

[[Page 399]]

combination with water (at least 50 percent) and capable of absorbing 
exudate. This classification does not include a hydrogel wound dressing 
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]