FDA 510(k)

Betel Gloves Nitrile Examination Glove Powder Free

Número K: K222342 · 2022-09-24

Data da decisão2022-09-24

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Betel Gloves Nitrile Examination Glove Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Betel Care Sdn. Bhd.. It received FDA 510(k) clearance on 2022-09-24 under 510(k) number K222342. 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 Betel Gloves Nitrile Examination Glove Powder Free?

Betel Gloves Nitrile Examination Glove Powder Free is a medical device that received FDA 510(k) clearance on 2022-09-24. The listed applicant is Betel Care Sdn. Bhd.. The 510(k) number is K222342.

When did Betel Gloves Nitrile Examination Glove Powder Free receive FDA 510(k) clearance?

Betel Gloves Nitrile Examination Glove Powder Free received FDA 510(k) clearance on 2022-09-24, under 510(k) number K222342.

Who is the listed applicant for Betel Gloves Nitrile Examination Glove Powder Free?

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

What is the FDA product code for Betel Gloves Nitrile Examination Glove Powder Free?

The FDA product code for Betel Gloves Nitrile Examination Glove Powder Free is LZA.

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Dispositivos Relacionados (Código: LZA)

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Fonte oficial

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