FDA 510(k)

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

N.º K: K221637 · 2022-09-29

SolicitanteAllmed Medical (Hubei) Protective Products Co., Ltd.

Fecha de decisión2022-09-29

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K221637. 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 (Sterile); Surgical Gown (Non-sterile)?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Allmed Medical (Hubei) Protective Products Co., Ltd.. The 510(k) number is K221637.

When did Surgical Gown (Sterile); Surgical Gown (Non-sterile) receive FDA 510(k) clearance?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) received FDA 510(k) clearance on 2022-09-29, under 510(k) number K221637.

Who is the listed applicant for Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

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

What is the FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

The FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile) is FYA.

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Otros registros que enlistan a Allmed Medical (Hubei) Protective Products Co., Ltd. como solicitante

K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

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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