FDA 510(k)

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

N.º K: K222480 · 2022-11-14

SolicitanteFoshan Nanhai Plus Medical Co, Ltd.

Fecha de decisión2022-11-14

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K222480. 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 Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K222480.

When did Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) receive FDA 510(k) clearance?

Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) received FDA 510(k) clearance on 2022-11-14, under 510(k) number K222480.

Who is the listed applicant for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

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

What is the FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)?

The FDA product code for Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) is FYA.

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Otros registros que enlistan a Foshan Nanhai Plus Medical Co, Ltd. como solicitante

K213177Plus Medical Cover Gown K211036Plus Medical Chemotherapy Gown K212698Plus Medical Isolation Gown Level 3 K212610Surgical Face Mask K210143Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

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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