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FDA 510(k)

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

Número K: K163146 · 2017-02-13

RequerenteHebei Hongsen Plastics Technology Co, Ltd.
Data da decisão2017-02-13
Código do produtoLZC
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K163146. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Hebei Hongsen Plastics Technology Co, Ltd.. The 510(k) number is K163146.

When did POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-02-13, under 510(k) number K163146.

Who is the listed applicant for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs?

The FDA product code for POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is LZC.

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Dispositivos Relacionados (Código: LZC)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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