21 CFR § 878.4493 - Absorbable poly(glycolide/l-lactide) surgical suture.

---
identifier: "/us/cfr/t21/s878.4493"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4493 - Absorbable poly(glycolide/l-lactide) surgical suture."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4493"
section_name: "Absorbable poly(glycolide/l-lactide) surgical suture."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 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) for the availability of this guidance document.

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