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FDA 510(k)

HG Pro Nitrile Powder Free Examination Gloves

K-Number: K152479 · 2016-04-04

Decision Date2016-04-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HG Pro Nitrile Powder Free Examination Gloves is a medical device manufactured by Healthy Glove Co., Ltd.. It received FDA 510(k) clearance on 2016-04-04 under approval number K152479. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Healthy Glove Co., Ltd.. The 510(k) number is K152479.

When was HG Pro Nitrile Powder Free Examination Gloves approved by the FDA?

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

What company makes HG Pro Nitrile Powder Free Examination Gloves?

HG Pro Nitrile Powder Free Examination Gloves is manufactured by Healthy Glove Co., Ltd..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.