New York Embroidery Studio (NYES)
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
SKU K252575UPC FYA
In Stock
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IIFDA 510(k) Cleared (K252575)
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Free shipping on orders over $99 · 30-day returns
New York Embroidery Studio (NYES)
Free shipping on orders over $99 · 30-day returns
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) is an FDA 510(k)-cleared medical device (K252575) manufactured by New York Embroidery Studio (NYES). This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2026. Regulation: 8.
