K252575
- 510(k) number
- K252575
- Device name
- Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- Applicant
- New York Embroidery Studio (NYES) NY · US
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-06-04
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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: K252575
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.