FDA 510(k)

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

Número K: K250564 · 2025-12-03

RequerenteYadu Medical (Henan) Co., Ltd.

Data da decisão2025-12-03

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Yadu Medical (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K250564. 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 Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Yadu Medical (Henan) Co., Ltd.. The 510(k) number is K250564.

When did Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) receive FDA 510(k) clearance?

Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) received FDA 510(k) clearance on 2025-12-03, under 510(k) number K250564.

Who is the listed applicant for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

The FDA 510(k) record lists Yadu Medical (Henan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)?

The FDA product code for Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) is FYA.

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Outros registros que listam Yadu Medical (Henan) Co., Ltd. como candidato(a)

K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)

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.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio 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

Fonte oficial

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