Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Disposable Nitrile Gloves (ABC-DG01)

Número K: K230542 · 2023-05-31

RequerenteHuizhou Anboson Technology Co., Ltd.
Data da decisão2023-05-31
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Nitrile Gloves (ABC-DG01) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Anboson Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K230542. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Nitrile Gloves (ABC-DG01)?

Disposable Nitrile Gloves (ABC-DG01) is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Huizhou Anboson Technology Co., Ltd.. The 510(k) number is K230542.

When did Disposable Nitrile Gloves (ABC-DG01) receive FDA 510(k) clearance?

Disposable Nitrile Gloves (ABC-DG01) received FDA 510(k) clearance on 2023-05-31, under 510(k) number K230542.

Who is the listed applicant for Disposable Nitrile Gloves (ABC-DG01)?

The FDA 510(k) record lists Huizhou Anboson Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Gloves (ABC-DG01)?

The FDA product code for Disposable Nitrile Gloves (ABC-DG01) is LZA.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LZA)

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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

↑