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FDA 510(k)

ELAZ Nitrile Powder Free Examination Glove

N.º K: K213604 · 2022-04-03

SolicitanteProtect Gloves Co., Ltd.
Fecha de decisión2022-04-03
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

ELAZ Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Protect Gloves Co., Ltd.. It received FDA 510(k) clearance on 2022-04-03 under 510(k) number K213604. 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 ELAZ Nitrile Powder Free Examination Glove?

ELAZ Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-04-03. The listed applicant is Protect Gloves Co., Ltd.. The 510(k) number is K213604.

When did ELAZ Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?

ELAZ Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-04-03, under 510(k) number K213604.

Who is the listed applicant for ELAZ Nitrile Powder Free Examination Glove?

The FDA 510(k) record lists Protect Gloves Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELAZ Nitrile Powder Free Examination Glove?

The FDA product code for ELAZ Nitrile Powder Free Examination Glove is LZA.

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Dispositivos relacionados (Código: LZA)

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.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Fuente oficial

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