FDA 510(k)

Medical Nitrile Examination Gloves (Power free, Blue)

N.º K: K210578 · 2021-07-10

SolicitanteJiangxi Hongda Medical Equipment Group , Ltd.

Fecha de decisión2021-07-10

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Nitrile Examination Gloves (Power free, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-10 under 510(k) number K210578. 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 Medical Nitrile Examination Gloves (Power free, Blue)?

Medical Nitrile Examination Gloves (Power free, Blue) is a medical device that received FDA 510(k) clearance on 2021-07-10. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210578.

When did Medical Nitrile Examination Gloves (Power free, Blue) receive FDA 510(k) clearance?

Medical Nitrile Examination Gloves (Power free, Blue) received FDA 510(k) clearance on 2021-07-10, under 510(k) number K210578.

Who is the listed applicant for Medical Nitrile Examination Gloves (Power free, Blue)?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Nitrile Examination Gloves (Power free, Blue)?

The FDA product code for Medical Nitrile Examination Gloves (Power free, Blue) is LZA.

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Otros registros que enlistan a Jiangxi Hongda Medical Equipment Group , Ltd. como solicitante

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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

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