FDA 510(k)

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE

K-Number: K172678 · 2017-11-24

Decision Date2017-11-24

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2017-11-24 under 510(k) 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. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K172678.

When did THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE receive FDA 510(k) clearance?

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

Who is the listed applicant for THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shen Wei USA, Inc. as applicant

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Related Devices (Code: LZA)

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Official Source

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