Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)— 510(k) K252575
Substantially EquivalentNew York Embroidery Studio (NYES)
FDA 510(k) clearance K252575 for Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L), Substantially Equivalent on 2026-06-04. Applicant: New York Embroidery Studio (NYES). Device class: 2.
Clearance details
- Applicant
- New York Embroidery Studio (NYES)
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.