FDA 510(k)

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

Número K: K252575 · 2026-06-04

RequerenteNew York Embroidery Studio (NYES)

Data da decisão2026-06-04

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) is the device name listed in this FDA 510(k) record. The listed applicant is New York Embroidery Studio (NYES). It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K252575. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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