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FDA 510(k)

Synthetic Nitrile Examination Gloves

K-Number: K212488 · 2021-11-26

ApplicantShandong Hongxin Chemicals Co., Ltd.
Decision Date2021-11-26
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthetic Nitrile Examination Gloves is a medical device manufactured by Shandong Hongxin Chemicals Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under approval number K212488. 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 Synthetic Nitrile Examination Gloves?

Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-26. It is manufactured by Shandong Hongxin Chemicals Co., Ltd.. The 510(k) number is K212488.

When was Synthetic Nitrile Examination Gloves approved by the FDA?

Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-26, under approval number K212488.

What company makes Synthetic Nitrile Examination Gloves?

Synthetic Nitrile Examination Gloves is manufactured by Shandong Hongxin Chemicals Co., Ltd..

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

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

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Official Source

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