[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: 21CFR878.4040]

[Page 368]
 
                        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. 878.4040  Surgical apparel.

    (a) Identification. Surgical apparel are devices that are intended 
to be worn by operating room personnel during surgical procedures to 
protect both the surgical patient and the operating room personnel from 
transfer of microorganisms, body fluids, and particulate material. 
Examples include surgical caps, hoods, masks, gowns, operating room 
shoes and shoe covers, and isolation masks and gowns. Surgical suits and 
dresses, commonly known as scrub suits, are excluded.
    (b) Classification. (1) Class II (special controls) for surgical 
gowns and surgical masks.
    (2) Class I (general controls) for surgical apparel other than 
surgical gowns and surgical masks. The class I device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2317, Jan. 14, 2000]