Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K-Number: K252575 · 2026-06-04
Device Summary
Frequently Asked Questions
What is the Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)?
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is New York Embroidery Studio (NYES). The 510(k) number is K252575.
When did Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) receive FDA 510(k) clearance?
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K252575.
Who is the listed applicant for Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)?
The FDA 510(k) record lists New York Embroidery Studio (NYES) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)?
The FDA product code for Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) is FYA.
Related Devices (Code: FYA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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