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FDA 510(k)

Biodegradable Nitrile Powder Free Examination Glove (Blue)

N.º K: K173509 · 2018-08-17

SolicitanteHartalega Sdn Bhd
Fecha de decisión2018-08-17
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Biodegradable Nitrile Powder Free Examination Glove (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K173509. 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 Biodegradable Nitrile Powder Free Examination Glove (Blue)?

Biodegradable Nitrile Powder Free Examination Glove (Blue) is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K173509.

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

Biodegradable Nitrile Powder Free Examination Glove (Blue) received FDA 510(k) clearance on 2018-08-17, under 510(k) number K173509.

Who is the listed applicant for Biodegradable Nitrile Powder Free Examination Glove (Blue)?

The FDA 510(k) record lists Hartalega Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue)?

The FDA product code for Biodegradable Nitrile Powder Free Examination Glove (Blue) is LZA.

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Otros registros que enlistan a Hartalega Sdn Bhd como solicitante

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K201748Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy DrugsK201531Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)K200897Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)K180645Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)K180786Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended CuffK180644Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green

Ver todos los 17 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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