[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: 21CFR880.5240]

[Page 397]
 
                        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. 880.5240  Medical adhesive tape and adhesive bandage.

    (a) Identification. A medical adhesive tape or adhesive bandage is a 
device intended for medical purposes that consists of a strip of fabric 
material or plastic, coated on one side with an adhesive, and may 
include a pad of surgical dressing without a disinfectant. The device is 
used to cover and protect wounds, to hold together the skin edges of a 
wound, to support an injured part of the body, or to secure objects to 
the skin.
    (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, l980, as amended at 59 FR 63011, Dec. 7, 
1994; 66 FR 38804, July 25, 2001]