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FDA 510(k)

Disposable Vinyl/Nitrile Blend Medical Examination Gloves

K-Number: K212899 · 2021-12-11

ApplicantBytech(Dongtai) Co., Ltd.
Decision Date2021-12-11
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is a medical device manufactured by Bytech(Dongtai) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-11 under approval number K212899. 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 Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-11. It is manufactured by Bytech(Dongtai) Co., Ltd.. The 510(k) number is K212899.

When was Disposable Vinyl/Nitrile Blend Medical Examination Gloves approved by the FDA?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves received FDA 510(k) clearance on 2021-12-11, under approval number K212899.

What company makes Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is manufactured by Bytech(Dongtai) Co., Ltd..

What is the FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

The FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves is LYZ.

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Related PubMed Literature

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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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