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FDA 510(k)

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

N.º K: K212869 · 2021-12-13

SolicitanteFugou County Shenxiang Manufacturing Co., Ltd.
Fecha de decisión2021-12-13
Código de productoFYA
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212869. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Fugou County Shenxiang Manufacturing Co., Ltd.. The 510(k) number is K212869.

When did Disposable Surgical Gown, Disposable Reinforced Surgical Gown receive FDA 510(k) clearance?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212869.

Who is the listed applicant for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA 510(k) record lists Fugou County Shenxiang Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown is FYA.

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Dispositivos relacionados (Código: FYA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 StudioK252575Tuff 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

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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