FDA 510(k)

Plus Medical Isolation Gown Level 3

Número K: K212698 · 2022-03-02

RequerenteFoshan Nanhai Plus Medical Co, Ltd.

Data da decisão2022-03-02

Código do produtoFYC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plus Medical Isolation Gown Level 3 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 2022-03-02 under 510(k) number K212698. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plus Medical Isolation Gown Level 3?

Plus Medical Isolation Gown Level 3 is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K212698.

When did Plus Medical Isolation Gown Level 3 receive FDA 510(k) clearance?

Plus Medical Isolation Gown Level 3 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212698.

Who is the listed applicant for Plus Medical Isolation Gown Level 3?

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 Plus Medical Isolation Gown Level 3?

The FDA product code for Plus Medical Isolation Gown Level 3 is FYC.

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Outros registros que listam Foshan Nanhai Plus Medical Co, Ltd. como candidato(a)

K222480Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)K213177Plus Medical Cover Gown K211036Plus Medical Chemotherapy Gown K212610Surgical Face Mask K210143Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

Dispositivos Relacionados (Código: FYC)

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

Fonte oficial

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