FDA 510(k)

HG Pro Nitrile Powder Free Examination Gloves

Número K: K152479 · 2016-04-04

Data da decisão2016-04-04

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HG Pro Nitrile Powder Free Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Healthy Glove Co., Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K152479. 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 HG Pro Nitrile Powder Free Examination Gloves?

HG Pro Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Healthy Glove Co., Ltd.. The 510(k) number is K152479.

When did HG Pro Nitrile Powder Free Examination Gloves receive FDA 510(k) clearance?

HG Pro Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2016-04-04, under 510(k) number K152479.

Who is the listed applicant for HG Pro Nitrile Powder Free Examination Gloves?

The FDA 510(k) record lists Healthy Glove Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HG Pro Nitrile Powder Free Examination Gloves?

The FDA product code for HG Pro Nitrile Powder Free Examination Gloves is LZA.

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Outros registros que listam Healthy Glove Co., Ltd. como candidato(a)

K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

Dispositivos Relacionados (Código: LZA)

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