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FDA 510(k)

Blue Nitrile Examination Gloves Powder Free

N.º K: K212584 · 2022-05-28

SolicitanteAmazing Rubber Products Pvt, Ltd.
Fecha de decisión2022-05-28
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Amazing Rubber Products Pvt, Ltd.. It received FDA 510(k) clearance on 2022-05-28 under 510(k) number K212584. 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 Blue Nitrile Examination Gloves Powder Free?

Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-05-28. The listed applicant is Amazing Rubber Products Pvt, Ltd.. The 510(k) number is K212584.

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

Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2022-05-28, under 510(k) number K212584.

Who is the listed applicant for Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Amazing Rubber Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Nitrile Examination Gloves Powder Free?

The FDA product code for Blue Nitrile Examination Gloves Powder Free is LZA.

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Otros registros que enlistan a Amazing Rubber Products Pvt, 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.

K212597Amazing+ Latex Examination Powder Free GlovesK212596Sterile Latex Surgical Gloves Powder FreeK212586Amazing+

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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