FDA 510(k)

Gown de Isolamento AAMI3

Número K: K213832 · 2022-05-16

RequerenteHubei Xinxin Non-Woven Co., Ltd.

Data da decisão2022-05-16

Código do produtoFYC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AAMI3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K213832. 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 AAMI3 Isolation Gown?

AAMI3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K213832.

When did AAMI3 Isolation Gown receive FDA 510(k) clearance?

AAMI3 Isolation Gown received FDA 510(k) clearance on 2022-05-16, under 510(k) number K213832.

Who is the listed applicant for AAMI3 Isolation Gown?

The FDA 510(k) record lists Hubei Xinxin Non-Woven Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AAMI3 Isolation Gown?

The FDA product code for AAMI3 Isolation 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 Hubei Xinxin Non-Woven Co., Ltd. como candidato(a)

K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)K214116Gown de Isolamento AAMI4 K212120Surgical Masks

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.