FDA 510(k)

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

Número K: K190159 · 2019-05-06

Data da decisão2019-05-06

Código do produtoLZC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is the device name listed in this FDA 510(k) record. The listed applicant is Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2019-05-06 under 510(k) number K190159. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is a medical device that received FDA 510(k) clearance on 2019-05-06. The listed applicant is Showa Best Glove, Inc.. The 510(k) number is K190159.

When did Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove receive FDA 510(k) clearance?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove received FDA 510(k) clearance on 2019-05-06, under 510(k) number K190159.

Who is the listed applicant for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA 510(k) record lists Showa Best Glove, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is LZC.

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 Showa Best Glove, Inc. como candidato(a)

K211003SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove K180468SBG Black Nitrile Powder Free Medical Examination Glove K180467SBG Blue Nitrile Powder Free Medical Examination Glove

Dispositivos Relacionados (Código: LZC)

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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.