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FDA 510(k)

Powder Free Nitrile Patient Examination Gloves, Blue Color

K-Number: K181106 · 2019-01-16

ApplicantJiangsu Dongxin Medical Technology Co., Ltd.
Decision Date2019-01-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device manufactured by Jiangsu Dongxin Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-01-16 under approval number K181106. 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 Patient Examination Gloves, Blue Color?

Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Jiangsu Dongxin Medical Technology Co., Ltd.. The 510(k) number is K181106.

When was Powder Free Nitrile Patient Examination Gloves, Blue Color approved by the FDA?

Powder Free Nitrile Patient Examination Gloves, Blue Color received FDA 510(k) clearance on 2019-01-16, under approval number K181106.

What company makes Powder Free Nitrile Patient Examination Gloves, Blue Color?

Powder Free Nitrile Patient Examination Gloves, Blue Color is manufactured by Jiangsu Dongxin Medical Technology Co., Ltd..

What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color?

The FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color 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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