Skip to main content
v2026.11,858 entries · CC-BY 4.0
LAC HealthMedical & Research SuppliesReagents, PPE & instruments — chain-of-custody documented.Fast, traceable sourcing built for regulated research environments, from bench consumables to instrumentation.Shop lac.us CodeCASRAIlac.us

Polyglycolic Acid (PGA) Suture: What It Is, How FDA Regulates It and What to Check

What polyglycolic acid is as a medical supply, how FDA regulates PGA absorbable sutures, and which attributes to confirm on a specification.

Written and maintained by CASRAI Editorial Board

Last updated

This page describes products and general use; it is not medical advice.

Who uses it: surgeons and clinical teams who close soft tissue, and the clinic staff, buyers and students who need to read a suture specification correctly. In medical supply, polyglycolic acid (PGA) usually means an absorbable suture strand made from the polymer polyglycolide.

What polyglycolic acid is, and how it differs from PLGA

Polyglycolic acid is a synthetic polymer made from glycolic acid units, also called polyglycolide. In medical supply it is best known as the material of absorbable surgical sutures. FDA’s suture regulation describes an absorbable strand prepared from homopolymers of glycolide, and from copolymers of 90 percent glycolide and 10 percent l-lactide, for use in soft tissue approximation (21 CFR 878.4493). The homopolymer is the PGA case.

PGA is not the same as PLGA, a copolymer of lactic and glycolic acid used in other biomedical applications. For sutures made from a different glycolide-based polymer, see polyglyconate.

How a PGA suture is built

An FDA 510(k) summary for the DEXON Violet suture (K972566, decision 14 August 1997) describes a synthetic, braided, absorbable surgical suture composed of polyglycolic acid homopolymer, coated with a glycolide and epsilon-caprolactone copolymer. That summary is a historical clearance record, not current product labeling. The regulation itself leaves several construction choices open: the strand may be monofilament or multifilament (braided), uncoated or coated, undyed or dyed with an FDA-approved color additive, and supplied with or without a standard needle attached. For needle terminology, see suture needle types. For the wider suture category, see what is a suture.

How FDA classifies PGA sutures

The regulation 21 CFR 878.4493 places this suture in Class II (special controls). The special control named in the regulation is the FDA guidance document “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” The regulation also states that the suture meets United States Pharmacopeia (U.S.P.) requirements for absorbable surgical sutures. A 2000 clearance for a PGA absorbable surgical suture (K002190, CP Medical) is listed under product code GAM and the same regulation. The regulation title names poly(glycolide/l-lactide); the glycolide homopolymer falls within its identification text.

How a PGA suture is absorbed

The K972566 summary states that tensile strength loss and absorption occur by hydrolysis, and that the polymer breaks down to glycolic acid, which the body metabolizes. Hydrolysis is a chemical breakdown by reaction with water. Strength-retention times differ by product and size, so use the manufacturer’s instructions for use for the specific suture rather than a general figure.

Types and variants

Attribute Options stated in 21 CFR 878.4493
Strand form Monofilament or multifilament (braided)
Surface Uncoated or coated
Color Undyed, or dyed with an FDA-approved color additive
Needle With or without a standard needle attached
Polymer Homopolymer of glycolide, or copolymer of 90 percent glycolide and 10 percent l-lactide
Regulatory class Class II (special controls)

What to confirm on a product specification

Each item below comes from the identification text of the regulation, so it is a fair attribute to confirm on a product’s labeling or specification sheet.

  • That the product is labeled as an absorbable, sterile surgical suture.
  • Whether the strand is monofilament or braided.
  • Whether it is coated, and with what.
  • Whether it is dyed or undyed.
  • Whether a needle is attached.
  • That the product states conformity to U.S.P. requirements for absorbable surgical sutures.

Braided PGA products sit alongside other braided closure materials in the braided sutures category.

Safe use and handling basics

The regulation describes a sterile, single strand device indicated for soft tissue approximation. The clearance summary for DEXON Violet lists general soft tissue approximation and/or ligation, including ophthalmic procedures, and states it is not cleared for cardiovascular or neurological procedures. That statement belongs to that 1997 clearance, so always follow the instructions for use supplied with the exact product, including its stated indications and cautions. This page does not describe clinical technique.

Common mistakes

  • Treating PGA and PLGA as the same material. They are different polymers with different uses.
  • Assuming every absorbable suture absorbs the same way. Compare the polymer and the labeling of each product, for example against what Monocryl suture is made of.
  • Relying on a historical clearance summary instead of the current instructions for use.

FAQ

What is polyglycolic acid used for?

In medical supply it is used to make absorbable surgical sutures for soft tissue approximation, as described in 21 CFR 878.4493.

Is PGA absorbable?

Yes. The FDA clearance summary for a PGA suture states that strength loss and absorption occur by hydrolysis, and the regulation classifies the device as an absorbable suture.

Is a PGA suture monofilament or braided?

The regulation allows both. The DEXON Violet summary describes a braided, coated PGA suture.

Sources

Follow CASRAI

Research-administration guidance, standards updates and independent tool reviews.

Ask CASRAI · free to try

Ask about Polyglycolic Acid (PGA) Suture: What It Is, How FDA Regulates It and What to Check

Ask your first 2 questions free below. Subscribers get 150 a day for $29 a month.

An AI assistant specialized in research administration. It cites the sources behind every answer, labels web answers and says when it can't answer.

Answers draw on CASRAI's guides and dictionary plus the federal and funder documents we index: Federal Register, Grants.gov, Regulations.gov and UKRI.

Works on this site and inside Claude, Cursor and the AI tools you already use.

Everything CASRAI publishes — this page, the dictionary, the guides and the news — stays free to read, with no account and no card.

Referenced across the research world

University of Cambridge logoColumbia University logoCrossref logoUniversity of Edinburgh logoHarvard University logoUniversity of Oxford logoPrinceton University logoStanford School of Medicine logoUniversity College London logoORCID logoUniversity of Cambridge logoColumbia University logoCrossref logoUniversity of Edinburgh logoHarvard University logoUniversity of Oxford logoPrinceton University logoStanford School of Medicine logoUniversity College London logoORCID logo
  • University of Cambridge logo
  • Columbia University logo
  • Crossref logo
  • University of Edinburgh logo
  • Harvard University logo
  • University of Oxford logo
  • Princeton University logo
  • Stanford School of Medicine logo
  • University College London logo
  • ORCID logo

View CASRAI adoption →