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FDA 510(k)

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color

K-Number: K161074 · 2016-11-17

ApplicantShen Wei (Usa), Inc.
Decision Date2016-11-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is a medical device manufactured by Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2016-11-17 under approval number K161074. 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 Powder Free Nitrile Examination Gloves Flock-Lined, Black Color?

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is a medical device that received FDA 510(k) clearance on 2016-11-17. It is manufactured by Shen Wei (Usa), Inc.. The 510(k) number is K161074.

When was Powder Free Nitrile Examination Gloves Flock-Lined, Black Color approved by the FDA?

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color received FDA 510(k) clearance on 2016-11-17, under approval number K161074.

What company makes Powder Free Nitrile Examination Gloves Flock-Lined, Black Color?

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is manufactured by Shen Wei (Usa), Inc..

What is the FDA product code for Powder Free Nitrile Examination Gloves Flock-Lined, Black Color?

The FDA product code for Powder Free Nitrile Examination Gloves Flock-Lined, Black Color is 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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