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FDA 510(k)

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

K-Number: K211209 · 2021-12-17

ApplicantHycare International Co., Ltd.
Decision Date2021-12-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is a medical device manufactured by Hycare International Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K211209. 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 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-17. It is manufactured by Hycare International Co., Ltd.. The 510(k) number is K211209.

When was Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves approved by the FDA?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves received FDA 510(k) clearance on 2021-12-17, under approval number K211209.

What company makes Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is manufactured by Hycare International Co., Ltd..

What is the FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is LZA.

Related Clinical Trials

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Related Devices (Code: LZA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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