NYES Tuff Cuff L3 Disposable Gowns— 510(k) K261949
Substantially EquivalentNew York Embroidery Studio
FDA 510(k) clearance K261949 for NYES Tuff Cuff L3 Disposable Gowns, Substantially Equivalent on 2026-07-10. Applicant: New York Embroidery Studio. Device class: 2.
Summary
New York Embroidery Studio's NYES Tuff Cuff L3 Disposable Gowns are filed under FYA, surgical gowns. The record doesn't expand "L3" or give materials.
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.
New York Embroidery Studio filed from Brooklyn, New York. The decision came 29 calendar days after receipt (June 11 to July 10, 2026).
Clearance details
- Applicant
- New York Embroidery Studio
- Product code
- Product 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
- Special
- Location
- Brooklyn, NY, US
Recent devices under product code FYA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.