K261949
- 510(k) number
- K261949
- Device name
- NYES Tuff Cuff L3 Disposable Gowns
- Applicant
- New York Embroidery Studio NY · US
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-07-10
- Date received
- 2026-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K261949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.