FDA 510(k)

Surgical Gown, Reinforced Surgical Gown

N.º K: K212861 · 2021-12-15

SolicitanteWuhan Zonsen Medical Products Co., Ltd.

Fecha de decisión2021-12-15

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Gown, Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K212861. 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 Surgical Gown, Reinforced Surgical Gown?

Surgical Gown, Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K212861.

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

Surgical Gown, Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-15, under 510(k) number K212861.

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

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

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

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

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Otros registros que enlistan a Wuhan Zonsen Medical Products Co., Ltd. como solicitante

K223600Sterilization Wrap K213601Surgical Mask K213688Nitrile Examination Gloves (Model: ZMG1351)K212357Surgical isolation gown K202191Surgical Mask

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

Fuente oficial

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