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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
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)
140 W 58th St., Bldg. A, Suite 8n
New York,  NY  11220
Applicant Contact Michelle Feinburg
Correspondent
Medical Devices Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Rob Packard
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/14/2025
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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