[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: 21CFR878.4480]

[Page 401]
 
                        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. 878.4480  Absorbable powder for lubricating a surgeon's glove.

    (a) Identification. Absorbable powder for lubricating a surgeon's 
glove is a powder made from corn starch that meets the specifications 
for absorbable powder in the United States Pharmacopeia (U.S.P.) and 
that is intended to be used to lubricate the surgeon's hand before 
putting on a surgeon's glove. The device is absorbable through 
biological degradation.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 878.3.