FDA 510(k)

Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs

Número K: K230002 · 2023-03-24

Data da decisão2023-03-24

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K230002. 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 Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs?

Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K230002.

When did Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2023-03-24, under 510(k) number K230002.

Who is the listed applicant for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs?

The FDA product code for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs is LZA.

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Outros registros que listam Mah Sing Healthcare Sdn. Bhd. como candidato(a)

K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue K223415Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K214110Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs K212535Nitrile Powder Free Blue Examination Gloves, Non-Sterile

Dispositivos Relacionados (Código: LZA)

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