FDA 510(k)

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Número K: K200181 · 2020-04-15

RequerenteComfort Rubber Gloves Industries Sdn. Bhd.

Data da decisão2020-04-15

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K200181. 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 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K200181.

When did Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2020-04-15, under 510(k) number K200181.

Who is the listed applicant for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

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

What is the FDA product code for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is LZA.

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Outros registros que listam Comfort Rubber Gloves Industries Sdn. Bhd. como candidato(a)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein K240269Nitrile Powder Free Examination Gloves Biodegradable (Green)K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

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Dispositivos Relacionados (Código: LZA)

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