FDA 510(k)

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)

Número K: K223401 · 2023-03-07

RequerenteXiamen Probtain Medical Techology Co., Ltd.

Data da decisão2023-03-07

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K223401. 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 (S,M,L,XL,XXL,XXXL)?

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K223401.

When did Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-03-07, under 510(k) number K223401.

Who is the listed applicant for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

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

What is the FDA product code for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)?

The FDA product code for Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) is FYA.

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Outros registros que listam Xiamen Probtain Medical Techology Co., Ltd. como candidato(a)

K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)K202954Disposable Surgical Mask K201893Disposable Surgical 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

Fonte oficial

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