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FDA 510(k)

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

K-Number: K182640 · 2019-04-12

ApplicantShandong Hengya Packaging Printing Co.,Ltd
Decision Date2019-04-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) is a medical device manufactured by Shandong Hengya Packaging Printing Co.,Ltd. It received FDA 510(k) clearance on 2019-04-12 under approval number K182640. 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, Blue and Violet Blue)?

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Shandong Hengya Packaging Printing Co.,Ltd. The 510(k) number is K182640.

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

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) received FDA 510(k) clearance on 2019-04-12, under approval number K182640.

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

Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) is manufactured by Shandong Hengya Packaging Printing Co.,Ltd.

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

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

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Related Devices (Code: LZA)

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Official Source

View on FDA Database →

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

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