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FDA 510(k)

Nitrile Exam Gloves (Blue, Black)

K-Number: K221143 · 2022-08-25

ApplicantHebei Astro Medical Supply Co., Ltd.
Decision Date2022-08-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Gloves (Blue, Black) is a medical device manufactured by Hebei Astro Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-08-25 under approval number K221143. 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 Nitrile Exam Gloves (Blue, Black)?

Nitrile Exam Gloves (Blue, Black) is a medical device that received FDA 510(k) clearance on 2022-08-25. It is manufactured by Hebei Astro Medical Supply Co., Ltd.. The 510(k) number is K221143.

When was Nitrile Exam Gloves (Blue, Black) approved by the FDA?

Nitrile Exam Gloves (Blue, Black) received FDA 510(k) clearance on 2022-08-25, under approval number K221143.

What company makes Nitrile Exam Gloves (Blue, Black)?

Nitrile Exam Gloves (Blue, Black) is manufactured by Hebei Astro Medical Supply Co., Ltd..

What is the FDA product code for Nitrile Exam Gloves (Blue, Black)?

The FDA product code for Nitrile Exam Gloves (Blue, Black) is LZA.

Other Devices by Hebei Astro Medical Supply Co., Ltd.

K213019Vinyl Exam Gloves

Related Devices (Code: LZA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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