21 CFR 878.5010
§ 878.5010 Nonabsorbable polypropylene surgical suture.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.5010, § 878.5010 Nonabsorbable polypropylene surgical suture, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90477
- Permanent ID
ys:prov:90477@1- SHA-256
2a7466752fda0fd341149388a33e68b7a9d577b7b682fc69b11624b8f49baec2
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Full text
(a) Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.