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FDA 510(k)

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

N.º K: K231408 · 2023-08-11

SolicitanteShandong Intco Medical Products Co, Ltd.
Fecha de decisión2023-08-11
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231408. 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 Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K231408.

When did Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile receive FDA 510(k) clearance?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231408.

Who is the listed applicant for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

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

What is the FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

The FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is LZA.

Ensayos clínicos relacionados

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Otros registros que enlistan a Shandong Intco Medical Products 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.

K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)K213509Latex Examination Gloves, Powder Free

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

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.

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