FDA 510(k)

Synthetic Polymer Glove - Polyethylene (Black)

Número K: K222531 · 2023-01-22

Data da decisão2023-01-22

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synthetic Polymer Glove - Polyethylene (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Ur Industry Sdn Bhd. It received FDA 510(k) clearance on 2023-01-22 under 510(k) number K222531. 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 Synthetic Polymer Glove - Polyethylene (Black)?

Synthetic Polymer Glove - Polyethylene (Black) is a medical device that received FDA 510(k) clearance on 2023-01-22. The listed applicant is Ur Industry Sdn Bhd. The 510(k) number is K222531.

When did Synthetic Polymer Glove - Polyethylene (Black) receive FDA 510(k) clearance?

Synthetic Polymer Glove - Polyethylene (Black) received FDA 510(k) clearance on 2023-01-22, under 510(k) number K222531.

Who is the listed applicant for Synthetic Polymer Glove - Polyethylene (Black)?

The FDA 510(k) record lists Ur Industry Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthetic Polymer Glove - Polyethylene (Black)?

The FDA product code for Synthetic Polymer Glove - Polyethylene (Black) 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.