FDA 510(k)

Proclean - Nitrile Powder Free Examination Gloves

Número K: K211374 · 2021-10-13

Data da decisão2021-10-13

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Proclean - Nitrile Powder Free Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Dr.Boo Company Limited. It received FDA 510(k) clearance on 2021-10-13 under 510(k) number K211374. 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 Proclean - Nitrile Powder Free Examination Gloves?

Proclean - Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-13. The listed applicant is Dr.Boo Company Limited. The 510(k) number is K211374.

When did Proclean - Nitrile Powder Free Examination Gloves receive FDA 510(k) clearance?

Proclean - Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2021-10-13, under 510(k) number K211374.

Who is the listed applicant for Proclean - Nitrile Powder Free Examination Gloves?

The FDA 510(k) record lists Dr.Boo Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proclean - Nitrile Powder Free Examination Gloves?

The FDA product code for Proclean - Nitrile Powder Free Examination Gloves 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_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

Dispositivos Relacionados (Código: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* 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.