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FDA 510(k)

NBR Synthetic Nitrile Examination Gloves

K-Number: K212436 · 2021-12-23

ApplicantShandong Langtai International Trade Co., Ltd.
Decision Date2021-12-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NBR Synthetic Nitrile Examination Gloves is a medical device manufactured by Shandong Langtai International Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-12-23 under approval number K212436. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NBR Synthetic Nitrile Examination Gloves?

NBR Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Shandong Langtai International Trade Co., Ltd.. The 510(k) number is K212436.

When was NBR Synthetic Nitrile Examination Gloves approved by the FDA?

NBR Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-12-23, under approval number K212436.

What company makes NBR Synthetic Nitrile Examination Gloves?

NBR Synthetic Nitrile Examination Gloves is manufactured by Shandong Langtai International Trade Co., Ltd..

What is the FDA product code for NBR Synthetic Nitrile Examination Gloves?

The FDA product code for NBR Synthetic Nitrile Examination Gloves is LYZ.

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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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