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FDA 510(k)

Blue Nitrile Examination Gloves Powder Free

N.º K: K192333 · 2020-01-24

SolicitanteJr Engineering & Medical Technologies (M) Sdn. Bhd.
Fecha de decisión2020-01-24
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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K192333. 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 2020-01-24. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K192333.

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 2020-01-24, under 510(k) number K192333.

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

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. 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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K222350Sterile Nitrile Surgical Gloves Powder FreeK221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateK222348JR MEDICK221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackK222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)K221157JR Medic

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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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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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