FDA 510(k)

Disposable Surgical Gowns

Número K: K202532 · 2021-08-21

RequerenteAnhui Medpurest Medical Technology Co.,Ltd

Data da decisão2021-08-21

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Gowns is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Medpurest Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-08-21 under 510(k) number K202532. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Surgical Gowns?

Disposable Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-08-21. The listed applicant is Anhui Medpurest Medical Technology Co.,Ltd. The 510(k) number is K202532.

When did Disposable Surgical Gowns receive FDA 510(k) clearance?

Disposable Surgical Gowns received FDA 510(k) clearance on 2021-08-21, under 510(k) number K202532.

Who is the listed applicant for Disposable Surgical Gowns?

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

What is the FDA product code for Disposable Surgical Gowns?

The FDA product code for Disposable Surgical Gowns is FYA.

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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

Fonte oficial

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