FDA 510(k)

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

Número K: K180452 · 2018-06-12

Data da decisão2018-06-12

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K180452. 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 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K180452.

When did White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim receive FDA 510(k) clearance?

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim received FDA 510(k) clearance on 2018-06-12, under 510(k) number K180452.

Who is the listed applicant for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

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

What is the FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim?

The FDA product code for White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim is LZA.

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Outros registros que listam Riverstone Resources Sdn Bhd como candidato(a)

K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim K200326Powder Free Nitrile Examination Glove (Aqua Green)K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Dispositivos Relacionados (Código: LZA)

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