[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: 21CFR878.4370]

[Page 369]
 
                        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. 878.4370  Surgical drape and drape accessories.

    (a) Identification. A surgical drape and drape accessories is a 
device made of natural or synthetic materials intended to be used as a 
protective patient covering, such as to isolate a site of surgical 
incision from microbial and other contamination. The device includes a 
plastic wound protector that may adhere to the skin around a surgical 
incision or be placed in a wound to cover its exposed edges, and a latex 
drape with a self-retaining finger cot that is intended to allow 
repeated insertion of the surgeon's finger into the rectum during 
performance of a transurethral prostatectomy.
    (b) Classification. Class II.