---
kind: "section"
citation: "21 C.F.R. § 878.4493"
title: "21"
number: "878.4493"
heading: "Absorbable poly(glycolide/l-lactide) surgical suture."
url: "https://uscodex.org/cfr/21/878.4493"
---

# §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 (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See [§ 878.1(e)](/cfr/21/878.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]