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FDA 510(k)

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)

N.º K: K221271 · 2022-07-27

SolicitanteShandong Maida Medical Technology Co., Ltd.
Fecha de decisión2022-07-27
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Maida Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K221271. 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 Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Shandong Maida Medical Technology Co., Ltd.. The 510(k) number is K221271.

When did Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2022-07-27, under 510(k) number K221271.

Who is the listed applicant for Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists Shandong Maida Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) 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.

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Otros registros que enlistan a Shandong Maida Medical Technology Co., Ltd. como solicitante

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.

K221192Disposable Nitrile Powder-Free Examination Gloves

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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