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FDA 510(k)

Thermoplastic Elastomer (TPE) Hybrid Examination Glove

K-Number: K210463 · 2022-01-23

ApplicantXuzhou Full Sun Medical Products , Ltd.
Decision Date2022-01-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a medical device manufactured by Xuzhou Full Sun Medical Products , Ltd.. It received FDA 510(k) clearance on 2022-01-23 under approval number K210463. 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 Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a medical device that received FDA 510(k) clearance on 2022-01-23. It is manufactured by Xuzhou Full Sun Medical Products , Ltd.. The 510(k) number is K210463.

When was Thermoplastic Elastomer (TPE) Hybrid Examination Glove approved by the FDA?

Thermoplastic Elastomer (TPE) Hybrid Examination Glove received FDA 510(k) clearance on 2022-01-23, under approval number K210463.

What company makes Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

Thermoplastic Elastomer (TPE) Hybrid Examination Glove is manufactured by Xuzhou Full Sun Medical Products , Ltd..

What is the FDA product code for Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

The FDA product code for Thermoplastic Elastomer (TPE) Hybrid Examination Glove is 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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