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FDA 510(k)

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE

K-Number: K172678 · 2017-11-24

ApplicantShen Wei USA, Inc.
Decision Date2017-11-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-11-24 under approval number K172678. 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 EXAMINATION (TPE) GLOVE?

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE is a medical device that received FDA 510(k) clearance on 2017-11-24. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K172678.

When was THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE approved by the FDA?

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE received FDA 510(k) clearance on 2017-11-24, under approval number K172678.

What company makes THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE?

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE is manufactured by Shen Wei USA, Inc..

What is the FDA product code for THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE?

The FDA product code for THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE is LZA.

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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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