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FDA 510(k)

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color

K-Number: K161074 · 2016-11-17

Decision Date2016-11-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves Flock-Lined, Black Color 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 2016-11-17 under 510(k) 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. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K161074.

When did Powder Free Nitrile Examination Gloves Flock-Lined, Black Color receive FDA 510(k) clearance?

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

Who is the listed applicant for Powder Free Nitrile Examination Gloves Flock-Lined, Black Color?

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 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.

Other records listing Shen Wei (Usa), Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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