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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 the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Full Sun Medical Products , Ltd.. It received FDA 510(k) clearance on 2022-01-23 under 510(k) 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. The listed applicant is Xuzhou Full Sun Medical Products , Ltd.. The 510(k) number is K210463.

When did Thermoplastic Elastomer (TPE) Hybrid Examination Glove receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermoplastic Elastomer (TPE) Hybrid Examination Glove?

The FDA 510(k) record lists Xuzhou Full Sun Medical Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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