FDA 510(k)

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

K-번호: K252575 · 2026-06-04

결정일2026-06-04

제품 코드FYA

자문 위원회SU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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

기기 요약

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관련 임상시험

관련 기기 (코드: FYA)

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