FDA 510(k)

ComfortGuard Surgical Gown, i600, Film Reinforced

N.º K: K163191 · 2017-02-27

SolicitanteGri Medical & Electrical Technology Co., Ltd.

Fecha de decisión2017-02-27

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ComfortGuard Surgical Gown, i600, Film Reinforced is the device name listed in this FDA 510(k) record. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-27 under 510(k) number K163191. 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 ComfortGuard Surgical Gown, i600, Film Reinforced?

ComfortGuard Surgical Gown, i600, Film Reinforced is a medical device that received FDA 510(k) clearance on 2017-02-27. The listed applicant is Gri Medical & Electrical Technology Co., Ltd.. The 510(k) number is K163191.

When did ComfortGuard Surgical Gown, i600, Film Reinforced receive FDA 510(k) clearance?

ComfortGuard Surgical Gown, i600, Film Reinforced received FDA 510(k) clearance on 2017-02-27, under 510(k) number K163191.

Who is the listed applicant for ComfortGuard Surgical Gown, i600, Film Reinforced?

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

What is the FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced?

The FDA product code for ComfortGuard Surgical Gown, i600, Film Reinforced is FYA.

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Otros registros que enlistan a Gri Medical & Electrical Technology Co., Ltd. como solicitante

K172445RoyalGuard Surgical Gown, i600, Breathable K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

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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