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FDA 510(k)

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)

K-Number: K170393 · 2017-05-09

ApplicantZibo Chengxun Automatic Device Co., Ltd.
Decision Date2017-05-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) is a medical device manufactured by Zibo Chengxun Automatic Device Co., Ltd.. It received FDA 510(k) clearance on 2017-05-09 under approval number K170393. 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 Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Zibo Chengxun Automatic Device Co., Ltd.. The 510(k) number is K170393.

When was Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) approved by the FDA?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) received FDA 510(k) clearance on 2017-05-09, under approval number K170393.

What company makes Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) is manufactured by Zibo Chengxun Automatic Device Co., Ltd..

What is the FDA product code for Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) is LZA.

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Related Devices (Code: 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.

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