FDA 510(k) clearance · back to tracker
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
New York Embroidery Studio (NYES) cleared K252575 on 2026-06-04, decision: substantially equivalent
K-number
K252575
Sponsor
New York Embroidery Studio (NYES)
Device
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-06-04
Product code
FYA
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4040
Official FDA record
Open K252575on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Raw record →
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.