Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information for supply and lab staff. It is not medical advice and does not describe how to close, care for or remove stitches.
Short answer
“Medical stitches” is the everyday name for surgical sutures: sterile threads or strands used for soft tissue approximation. In a supply catalogue the same item is listed as a suture and described by material, absorbable status, size, construction, length and needle. This page maps the word “stitches” to those catalogue fields and to the documents that back them.
Definition and scope: stitch, suture and the other closure products
Healthline’s guide to sutures (last updated 2018-04-06) calls the suture the medical device and stitching the technique. In supply work the distinction matters because only the device has a label, a lot number and a regulatory entry. A search for “medical stitches” or “medical sutures” therefore usually lands on the device.
The United States Pharmacopeia text for nonabsorbable surgical suture (USP 35) defines a suture as “a flexible strand of material that is suitably resistant to the action of living mammalian tissue.” Products that close skin without a thread are different device types; CASRAI covers them separately, for example the butterfly closure.
How a stitch request translates into a catalogue entry
FDA regulates sutures as classified devices. Two examples of how the federal regulations describe them (21 CFR, eCFR):
- Nonabsorbable polyethylene terephthalate (PET) suture, 21 CFR 878.5000: “a multifilament, nonabsorbable, sterile, flexible thread” prepared from high molecular weight, long-chain, linear polyesters and indicated for use in soft tissue approximation. It may be coated or uncoated, undyed or dyed with an FDA-listed color additive, and supplied with or without a standard needle. It must meet the USP monograph for nonabsorbable surgical sutures, and it is Class II (special controls).
- Absorbable poly(glycolide/L-lactide) suture, 21 CFR 878.4493: an “absorbable sterile, flexible strand” made from homopolymers of glycolide and copolymers of 90 percent glycolide and 10 percent L-lactide, “indicated for use in soft tissue approximation.” It may be monofilament or multifilament (braided), coated or uncoated, with or without a standard needle attached, must meet the USP monograph for absorbable surgical sutures, and is Class II.
Both entries name the USP monograph as the performance reference, and the special control for each is the FDA guidance “Class II Special Controls Guidance Document: Surgical Sutures”. FDA also has a guidance page, “Surgical Sutures – Performance Criteria for Safety and Performance Based Pathway” (April 2022), which lets a submitter use FDA’s performance criteria in a 510(k) in place of a direct comparison to a predicate device.
Types and related terms
Two plain-language pairs cover most of what a requester means. For absorbable status, see absorbable vs non-absorbable sutures. For thread construction, see monofilament vs multifilament suture. The two CFR entries above show both axes at work: the PET suture is multifilament and nonabsorbable, while the glycolide suture is absorbable and may be monofilament or braided.
Specific products described elsewhere on CASRAI include the stainless steel suture, the PTFE suture and FiberWire. A suture sold with a needle already attached is covered under swaged needle.
Where it matters for labs, clinics and supply decisions: a label-field checklist
The USP 35 monograph says a sterile suture is packaged in a container designed so that sterility is maintained until the container is opened, and that the packet label indicates the material, size, construction, length, sterility status, needle type if one is included, a lot identifier and the manufacturer or distributor. The table turns those statements into a document check. Each row is traced to the source named in the last column.
| Field to check | What the source says | Source |
|---|---|---|
| Material | Packet label states the material; the CFR entries name the polymer class (for example PET or glycolide/L-lactide) | USP 35; 21 CFR 878.5000, 878.4493 |
| Absorbable status | Each CFR entry is either “nonabsorbable” or “absorbable” and points to the matching USP monograph | 21 CFR 878.5000, 878.4493 |
| Size | Indicated on the packet label; diameter and tensile strength correspond to the size designation on the label | USP 35 |
| Construction | Packet label states construction; CFR entries distinguish multifilament, monofilament and braided forms | USP 35; 21 CFR 878.5000, 878.4493 |
| Length | Listed on the packet label | USP 35 |
| Needle | Packet label gives the needle type if one is included; the CFR entries allow supply with or without a standard needle | USP 35; 21 CFR 878.5000, 878.4493 |
| Sterile or non-sterile | Packet label states sterility status; sterile packaging maintains sterility until opened | USP 35 |
| Lot identifier | Listed on the packet label | USP 35 |
| Manufacturer, packer or distributor | Box label gives the address of the manufacturer, packer or distributor, plus the composition of any packaging fluids used | USP 35 |
The USP 35 text is a 2012 edition; check the current USP-NF before treating any monograph wording as the present requirement. The same list of fields doubles as a short set of questions for a supplier: which USP monograph the product conforms to, what the sterility statement on the packet is, and how lots are identified on the label. For how a catalogue entry can be organised and checked, see the medical supply catalog guide.
Common misunderstandings
“Stitches” and “sutures” are two different products
In Healthline’s wording, the suture is the device and stitching is the technique. A catalogue search for the device uses “suture”.
A thread-free closure is a suture
The regulations above describe sutures as threads or strands. Tapes and strips are other product types.
Size is just a number
In the USP 35 text, the size on the label corresponds to diameter and tensile strength limits, so it should be read with the material and construction, not alone.
FAQ
What are medical stitches called in a catalogue?
Surgical sutures. The product is described by material, absorbable status, size, construction, length and whether a needle is attached.
What are medical sutures made of?
The two federal entries cited on this page cover a polyester (PET) nonabsorbable thread and absorbable glycolide and glycolide/L-lactide strands. Other materials have their own entries; see the product guides linked above.
How does FDA classify a surgical suture?
The two entries cited on this page, 21 CFR 878.5000 and 878.4493, are both Class II (special controls), with FDA’s Class II special controls guidance on surgical sutures as the special control.
Sources
- eCFR, 21 CFR 878.5000, Nonabsorbable polyethylene terephthalate surgical suture – https://www.ecfr.gov/current/title-21/part-878/section-878.5000 (checked 2026-11-01)
- eCFR, 21 CFR 878.4493, Absorbable poly(glycolide/L-lactide) surgical suture – https://www.ecfr.gov/current/title-21/part-878/section-878.4493 (checked 2026-11-01)
- FDA, Surgical Sutures – Performance Criteria for Safety and Performance Based Pathway – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-sutures-performance-criteria-safety-and-performance-based-pathway (checked 2026-11-01)
- USP 35-NF 30, Nonabsorbable Surgical Suture monograph (hosted copy) – https://www.drugfuture.com/Pharmacopoeia/USP35/data/v35300/usp35nf30s0_m80200.html (checked 2026-11-01)
- Healthline, Sutures – https://www.healthline.com/health/sutures (last updated 2018-04-06; checked 2026-11-01)
