FDA 510(k)

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs

Número K: K170686 · 2017-07-14

Data da decisão2017-07-14

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs 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 2017-07-14 under 510(k) number K170686. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs?

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K170686.

When did Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-07-14, under 510(k) number K170686.

Who is the listed applicant for Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs?

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 Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs?

The FDA product code for Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs is LZA.

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Outros registros que listam Brightway Holdings Sdn. Bhd. como candidato(a)

K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM K163267NITRILE EXAMINATION GLOVE K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: LZA)

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