FDA 510(k)

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

Número K: K261028 · 2026-08-07

RequerenteYadu Medical (Henan) Co., Ltd.

Data da decisão2026-08-07

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Gown Level2 (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 2026-08-07 under 510(k) number K261028. 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 Level2 (S, M, L, XL, XXL, XXXL)?

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Yadu Medical (Henan) Co., Ltd.. The 510(k) number is K261028.

When did Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) receive FDA 510(k) clearance?

Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261028.

Who is the listed applicant for Surgical Gown Level2 (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 Level2 (S, M, L, XL, XXL, XXXL)?

The FDA product code for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) is FYA.

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

K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

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.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 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

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