FDA 510(k)

AMADEX - Guantes de examen sin látex de nitrilo (Azul, Negro, Naranja)

N.º K: K211310 · 2021-06-16

Fecha de decisión2021-06-16

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is the device name listed in this FDA 510(k) record. The listed applicant is Megine Industries Sdn Bhd. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K211310. 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 AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Megine Industries Sdn Bhd. The 510(k) number is K211310.

When did AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) receive FDA 510(k) clearance?

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) received FDA 510(k) clearance on 2021-06-16, under 510(k) number K211310.

Who is the listed applicant for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

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

What is the FDA product code for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)?

The FDA product code for AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) 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 Megine Industries Sdn Bhd como solicitante

K220232Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

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.