[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4493]

[Page 376]
 
                        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. 878.4493  Absorbable poly(glycolide/l-lactide) surgical suture.

    (a) Identification. An absorbable poly(glycolide/l-lactide) surgical 
suture (PGL suture) is an absorbable sterile, flexible strand as 
prepared and synthesized from homopolymers of glycolide and copolymers 
made from 90 percent glycolide and 10 percent l-lactide, and is 
indicated for use in soft tissue approximation. A PGL suture meets 
United States Pharmacopeia (U.S.P.) requirements as described in the 
U.S.P. ``Monograph for Absorbable Surgical Sutures;'' it may be 
monofilament or multifilament (braided) in form; it may be uncoated or 
coated; and it may be undyed or dyed with an FDA-approved color 
additive. Also, the suture may be provided with or without a standard 
needle attached.
    (b) Classification. Class II.

[56 FR 47151, Sept. 18, 1991]