FDA 510(k)

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves

Número K: K171737 · 2017-12-29

RequerenteAnsell Healthcare Products, LLC

Data da decisão2017-12-29

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2017-12-29 under 510(k) number K171737. 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 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-12-29. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171737.

When did Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves receive FDA 510(k) clearance?

Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves received FDA 510(k) clearance on 2017-12-29, under 510(k) number K171737.

Who is the listed applicant for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves?

The FDA product code for Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves is LZA.

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