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FDA 510(k)

Synthetic Vinyl Examination Gloves

K-Number: K212002 · 2021-09-23

ApplicantYunnan Huazhiyuan Medical Technology Co., Ltd.
Decision Date2021-09-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthetic Vinyl Examination Gloves is a medical device manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under approval number K212002. 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 Vinyl Examination Gloves?

Synthetic Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K212002.

When was Synthetic Vinyl Examination Gloves approved by the FDA?

Synthetic Vinyl Examination Gloves received FDA 510(k) clearance on 2021-09-23, under approval number K212002.

What company makes Synthetic Vinyl Examination Gloves?

Synthetic Vinyl Examination Gloves is manufactured by Yunnan Huazhiyuan Medical Technology Co., Ltd..

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

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

Related Clinical Trials

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Other Devices by Yunnan Huazhiyuan Medical Technology Co., Ltd.

K213051Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) K210686Nitrile Patient Examination Glove K210799Powder Free Vinyl Patient Examination Gloves

Related Devices (Code: 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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