FDA 510(k)

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

N.º K: K230314 · 2023-08-16

Fecha de decisión2023-08-16

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is the device name listed in this FDA 510(k) record. The listed applicant is New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230314. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is New Era Medicare Sdn. Bhd.. The 510(k) number is K230314.

When did Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) receive FDA 510(k) clearance?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230314.

Who is the listed applicant for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

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

What is the FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

The FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is LZA.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a New Era Medicare Sdn. Bhd. como solicitante

K221424Sterile Surgical Powder Free Latex Glove K221667Non Sterile Powder Free Latex Examination Glove

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.