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FDA 510(k)

Medical Examination Gloves

K-Number: K213168 · 2022-01-11

Decision Date2022-01-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Examination Gloves is a medical device manufactured by Shandong Huiwosheng Health Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-01-11 under approval number K213168. 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 Medical Examination Gloves?

Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Shandong Huiwosheng Health Technology Co.,Ltd. The 510(k) number is K213168.

When was Medical Examination Gloves approved by the FDA?

Medical Examination Gloves received FDA 510(k) clearance on 2022-01-11, under approval number K213168.

What company makes Medical Examination Gloves?

Medical Examination Gloves is manufactured by Shandong Huiwosheng Health Technology Co.,Ltd.

What is the FDA product code for Medical Examination Gloves?

The FDA product code for Medical Examination Gloves is LZA.

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Official Source

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