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FDA 510(k)

BIOTECH Nitrile Examination Gloves

N.º K: K202419 · 2021-04-16

SolicitanteTk Hitech Technology Co., Ltd.
Fecha de decisión2021-04-16
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

BIOTECH Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Tk Hitech Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K202419. 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 BIOTECH Nitrile Examination Gloves?

BIOTECH Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Tk Hitech Technology Co., Ltd.. The 510(k) number is K202419.

When did BIOTECH Nitrile Examination Gloves receive FDA 510(k) clearance?

BIOTECH Nitrile Examination Gloves received FDA 510(k) clearance on 2021-04-16, under 510(k) number K202419.

Who is the listed applicant for BIOTECH Nitrile Examination Gloves?

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

What is the FDA product code for BIOTECH Nitrile Examination Gloves?

The FDA product code for BIOTECH Nitrile Examination Gloves is LZA.

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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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