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FDA 510(k)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

N.º K: K162186 · 2017-03-31

SolicitanteBrightway Holdings Sdn. Bhd.
Fecha de decisión2017-03-31
Código de productoLZC
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162186. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K162186.

When did BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM receive FDA 510(k) clearance?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162186.

Who is the listed applicant for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

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

What is the FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM?

The FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is LZC.

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Otros registros que enlistan a Brightway Holdings Sdn. Bhd. como solicitante

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K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsK162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGSK163267NITRILE EXAMINATION GLOVEK162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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