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FDA 510(k)

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

K-Number: K213144 · 2021-12-22

ApplicantShen Wei USA, Inc.
Decision Date2021-12-22
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is a medical device manufactured by Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213144. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Shen Wei USA, Inc.. The 510(k) number is K213144.

When was Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors approved by the FDA?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors received FDA 510(k) clearance on 2021-12-22, under approval number K213144.

What company makes Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is manufactured by Shen Wei USA, Inc..

What is the FDA product code for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors?

The FDA product code for Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors is LYZ.

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Related Devices (Code: LYZ)

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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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