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FDA 510(k)

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

K-Number: K190159 · 2019-05-06

ApplicantShowa Best Glove, Inc.
Decision Date2019-05-06
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is a medical device manufactured by Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2019-05-06 under approval number K190159. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by Showa Best Glove, Inc.. The 510(k) number is K190159.

When was Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove approved by the FDA?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove received FDA 510(k) clearance on 2019-05-06, under approval number K190159.

What company makes Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is manufactured by Showa Best Glove, Inc..

What is the FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove?

The FDA product code for Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove is LZC.

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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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