# Dukal LLC (specification developer, Ronkonkoma, NY): 3 new FDA device listings, incl. wound dressing with animal-derived material(s)

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Dukal LLC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Ronkonkoma, NY, US |
| New listings | 3 |
| Devices | Wound Dressing With Animal-Derived Material(S); Vinyl Patient Examination Glove; Polymer Patient Examination Glove |
| Product codes | KGN, LYZ, LZA |
| Device classes | Class I, Unclassified |
| Medical specialties | General Hospital |
| Brand names | RENCURA™ Sterile Collagen Wound Dressing; Private Label Vinyl Patient Exam gloves; Private Label Polymer (Nitrile) patient examination glove |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 2435946 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.