BETA
Kyiv-based manufacturer of absorbable and non-absorbable surgical sutures, with U.S. clearances documented for Golnit PTFE and nylon monofilament products through Antarma LLC dba Golnit Sutures.
Golnit Ltd designs, manufactures and distributes surgical sutures and needle combinations. Established in 1987, the company’s main office and manufacturing operation are in Kyiv, Ukraine. Its catalog spans dental, cardiovascular, ophthalmic, general-surgery and other applications, with absorbable and non-absorbable materials. It reports an ISO 7 cleanroom, in-house quality-control laboratory and ethylene-oxide sterilization capability.
FDA records document original PTFE clearance K163049 in June 2017, an expanded PTFE indication under K192088 in September 2019, and nylon monofilament clearance K212888 in March 2022. The applicant is Antarma LLC dba Golnit Sutures, identified by Golnit as its New York sales office. FDA establishment listings separately identify Golnit Ltd in Ukraine as a contract manufacturer. Registration is distinct from product clearance, and the wider catalog is not automatically covered by these decisions.
Golnit sells through its own online store and identifies Net32 as a purchasing channel for U.S. dental clinics. Current marketplace listings include PTFE and nylon products, supporting commercial availability rather than a measure of clinical adoption. The company says its PTFE line launched in 2011. Current headcount, revenue, financing, Ukrainian executive leadership and named institutional deployments were not independently verified.
Searches under Golnit and Antarma reverified three 510(k) decisions: K163049 and K192088 for PTFE/ePTFE sutures, and K212888 for nylon monofilament sutures. The later PTFE decision expands the original oral indication, with specific exclusions in the labeling. Those decisions do not substantiate the website’s broader claim that all catalog materials are FDA-cleared; absorbable and other non-absorbable materials remain separately unverified for U.S. authorization. U.S. authorization was not established for the absorbable and other non-absorbable catalog materials beyond the three documented PTFE/nylon decisions. [3][2][4][23][24][20][12][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [8][6]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
Sterile single-use PTFE monofilament sutures, marketed in dental and cardiovascular configurations. Exact needle and size combinations require label matching. [18][17][29][22][23]
FDA-clearedCurrent manufacturer portfolio and direct / Net32 listings.
Sterile single-use nylon monofilament sutures with or without surgical needles in specified sizes and configurations. [19][29][24]
FDA-clearedCurrent manufacturer portfolio and Net32 listings.
Catalog includes PGA and PGA Rapid, polyglactin 910 variants, polydioxanone, poliglecaprone 25, and plain/chromic catgut. [12]
Marketed · regulatory scope variesMarketed in manufacturer catalog; U.S. authorization and availability not established for this grouped portfolio.
Additional marketed materials outside the two U.S. clearance mappings documented here. [16]
Marketed · regulatory scope variesMarketed in manufacturer catalog; U.S. clearance and SKU availability not established.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Net32 (marketplace) [20][29] | United States — dental purchasing channel | Golnit PTFE and nylon monofilament sutures |
Sources checked October 17, 2026.
FDA cleared K212888 for general soft tissue approximation or ligation including ophthalmic procedures, excluding cardiovascular and neurological uses. [26]
FDA special 510(k) K192088 added broader soft-tissue uses, including cardiovascular procedures and dura mater repair, with specified exclusions. [25]
FDA cleared K163049 for Golnit PTFE sutures for oral-cavity soft tissue approximation/ligation and barrier-membrane fixation. Applicant was Antarma dba Golnit Sutures. [22]
Company reports launch of its PTFE suture product line in 2011; subsequent product-page dates are not original launch dates. [11]
Company history identifies 1987 as the start of its surgical suture manufacturing activity. [11]
Accessed 10/20/2026