FDA 510(k)

Surgical Isolation Cover Gown

Número K: K220528 · 2022-06-10

RequerenteWuhan Dymex Healthcare Co., Ltd.

Data da decisão2022-06-10

Código do produtoFYC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Isolation Cover Gown is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Dymex Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K220528. 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 Surgical Isolation Cover Gown?

Surgical Isolation Cover Gown is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Wuhan Dymex Healthcare Co., Ltd.. The 510(k) number is K220528.

When did Surgical Isolation Cover Gown receive FDA 510(k) clearance?

Surgical Isolation Cover Gown received FDA 510(k) clearance on 2022-06-10, under 510(k) number K220528.

Who is the listed applicant for Surgical Isolation Cover Gown?

The FDA 510(k) record lists Wuhan Dymex Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Isolation Cover Gown?

The FDA product code for Surgical Isolation Cover Gown is FYC.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Wuhan Dymex Healthcare Co., Ltd. como candidato(a)

K211809Surgical Gown K210433Surgical Face Mask (Ear loops and Tie-on)K182515Surgical Face Mask

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.