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FDA 510(k)

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

K-Number: K202078 · 2021-03-05

ApplicantShen Wei USA, Inc.
Decision Date2021-03-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval number K202078. 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 Biodegradable Thermoplastic Elastomer Examination (TPE) Glove?

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K202078.

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

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove received FDA 510(k) clearance on 2021-03-05, under approval number K202078.

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

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is manufactured by Shen Wei USA, Inc..

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

The FDA product code for Biodegradable Thermoplastic Elastomer Examination (TPE) Glove is LZA.

Other Devices by Shen Wei USA, Inc.

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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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