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FDA 510(k)

Disposable Nitrile Examination Glove

K-Number: K212661 · 2021-11-19

ApplicantInner Mongolia Cureguard Medical Technology Co., Ltd.
Decision Date2021-11-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Examination Glove is a medical device manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under approval number K212661. 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 Disposable Nitrile Examination Glove?

Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd.. The 510(k) number is K212661.

When was Disposable Nitrile Examination Glove approved by the FDA?

Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-11-19, under approval number K212661.

What company makes Disposable Nitrile Examination Glove?

Disposable Nitrile Examination Glove is manufactured by Inner Mongolia Cureguard Medical Technology Co., Ltd..

What is the FDA product code for Disposable Nitrile Examination Glove?

The FDA product code for Disposable Nitrile Examination Glove is LZA.

Other Devices by Inner Mongolia Cureguard Medical Technology Co., Ltd.

K212401Disposable Nitrile Examination Glove K222642Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

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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