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FDA 510(k)

Disposable Medical Nitrile Examination Gloves

K-Number: K223895 · 2023-03-23

Decision Date2023-03-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves is a medical device manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under approval number K223895. 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 Disposable Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K223895.

When was Disposable Medical Nitrile Examination Gloves approved by the FDA?

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2023-03-23, under approval number K223895.

What company makes Disposable Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is manufactured by Hebei Titans Hongsen Medical Technology Co., Ltd..

What is the FDA product code for Disposable Medical Nitrile Examination Gloves?

The FDA product code for Disposable Medical Nitrile 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.