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FDA 510(k)

Nitrile Exam Gloves, Powder Free, Blue

K-Number: K211699 · 2021-08-20

Decision Date2021-08-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Gloves, Powder Free, Blue is a medical device manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-20 under approval number K211699. 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 Nitrile Exam Gloves, Powder Free, Blue?

Nitrile Exam Gloves, Powder Free, Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd.. The 510(k) number is K211699.

When was Nitrile Exam Gloves, Powder Free, Blue approved by the FDA?

Nitrile Exam Gloves, Powder Free, Blue received FDA 510(k) clearance on 2021-08-20, under approval number K211699.

What company makes Nitrile Exam Gloves, Powder Free, Blue?

Nitrile Exam Gloves, Powder Free, Blue is manufactured by Hengchang (Dongying) Medical Technology Co., Ltd..

What is the FDA product code for Nitrile Exam Gloves, Powder Free, Blue?

The FDA product code for Nitrile Exam Gloves, Powder Free, Blue is LZA.

Other Devices by Hengchang (Dongying) Medical Technology Co., Ltd.

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Official Source

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