FDA 510(k)

NYES Tuff Cuff L3 Disposable Gowns

Número K: K261949 · 2026-07-10

Data da decisão2026-07-10

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NYES Tuff Cuff L3 Disposable Gowns is the device name listed in this FDA 510(k) record. The listed applicant is New York Embroidery Studio. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261949. 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 NYES Tuff Cuff L3 Disposable Gowns?

NYES Tuff Cuff L3 Disposable Gowns is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is New York Embroidery Studio. The 510(k) number is K261949.

When did NYES Tuff Cuff L3 Disposable Gowns receive FDA 510(k) clearance?

NYES Tuff Cuff L3 Disposable Gowns received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261949.

Who is the listed applicant for NYES Tuff Cuff L3 Disposable Gowns?

The FDA 510(k) record lists New York Embroidery Studio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYES Tuff Cuff L3 Disposable Gowns?

The FDA product code for NYES Tuff Cuff L3 Disposable Gowns is FYA.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: FYA)

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.