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FDA 510(k)

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves

K-Number: K221229 · 2022-07-16

ApplicantZibo Blue Sail Health Technology Co., Ltd.
Decision Date2022-07-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is a medical device manufactured by Zibo Blue Sail Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-16 under approval number K221229. 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, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-07-16. It is manufactured by Zibo Blue Sail Health Technology Co., Ltd.. The 510(k) number is K221229.

When was Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves approved by the FDA?

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves received FDA 510(k) clearance on 2022-07-16, under approval number K221229.

What company makes Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is manufactured by Zibo Blue Sail Health Technology Co., Ltd..

What is the FDA product code for Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves?

The FDA product code for Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves is LZA.

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Related Devices (Code: 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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