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FDA 510(k)

Powder Free Nitrile Examination Gloves (Black)

N.º K: K232353 · 2023-08-31

SolicitanteShanxi Hongjin Plastic Technology Co., Ltd.
Fecha de decisión2023-08-31
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Examination Gloves (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K232353. 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 Powder Free Nitrile Examination Gloves (Black)?

Powder Free Nitrile Examination Gloves (Black) is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. The 510(k) number is K232353.

When did Powder Free Nitrile Examination Gloves (Black) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (Black) received FDA 510(k) clearance on 2023-08-31, under 510(k) number K232353.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (Black)?

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

What is the FDA product code for Powder Free Nitrile Examination Gloves (Black)?

The FDA product code for Powder Free Nitrile Examination Gloves (Black) is LZA.

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Otros registros que enlistan a Shanxi Hongjin Plastic Technology Co., Ltd. como solicitante

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K232550Nitrile Examination Gloves, Dual Color Black-BlueK230779Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK220229Powder Free Nitrile Examination Gloves, OrangeK211604Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy DrugsK180381Powder Free Vinyl Patient Examination GlovesK180260Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Ver todos los 7 dispositivos →

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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