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FDA 510(k)

Blue Nitrile Exam Gloves

K-Number: K211341 · 2021-07-29

ApplicantJiangxi Surefine Medical Co., Ltd.
Decision Date2021-07-29
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Blue Nitrile Exam Gloves is a medical device manufactured by Jiangxi Surefine Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-07-29 under approval number K211341. 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 Blue Nitrile Exam Gloves?

Blue Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by Jiangxi Surefine Medical Co., Ltd.. The 510(k) number is K211341.

When was Blue Nitrile Exam Gloves approved by the FDA?

Blue Nitrile Exam Gloves received FDA 510(k) clearance on 2021-07-29, under approval number K211341.

What company makes Blue Nitrile Exam Gloves?

Blue Nitrile Exam Gloves is manufactured by Jiangxi Surefine Medical Co., Ltd..

What is the FDA product code for Blue Nitrile Exam Gloves?

The FDA product code for Blue Nitrile Exam Gloves is LZA.

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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