[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: 21CFR880.5300]

[Page 383]
 
                        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. 880.5300  Medical absorbent fiber.

    (a) Identification. A medical absorbent fiber is a device intended 
for medical purposes that is made from cotton or synthetic fiber in the 
shape of a ball or a pad and that is used for applying medication to, or 
absorbing small amounts of body fluids from, a patient's body surface. 
Absorbent fibers intended solely for cosmetic purposes are not included 
in this generic device category.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice regulation in part 820, 
with the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.