FDA 510(k)

Ivory Glove Powder-Free Nitrile Examination Gloves

Número K: K213681 · 2022-04-21

Data da decisão2022-04-21

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ivory Glove Powder-Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Gloves Sdn. Bhd.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213681. 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 Ivory Glove Powder-Free Nitrile Examination Gloves?

Ivory Glove Powder-Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Ivory Gloves Sdn. Bhd.. The 510(k) number is K213681.

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

Ivory Glove Powder-Free Nitrile Examination Gloves received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213681.

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

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

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

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

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