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FDA 510(k)

Examination gloves -Type C (Nitrile gloves)

K-Number: K212290 · 2021-10-28

ApplicantJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Decision Date2021-10-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Examination gloves -Type C (Nitrile gloves) is a medical device manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. It received FDA 510(k) clearance on 2021-10-28 under approval number K212290. 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 Examination gloves -Type C (Nitrile gloves)?

Examination gloves -Type C (Nitrile gloves) is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. The 510(k) number is K212290.

When was Examination gloves -Type C (Nitrile gloves) approved by the FDA?

Examination gloves -Type C (Nitrile gloves) received FDA 510(k) clearance on 2021-10-28, under approval number K212290.

What company makes Examination gloves -Type C (Nitrile gloves)?

Examination gloves -Type C (Nitrile gloves) is manufactured by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd..

What is the FDA product code for Examination gloves -Type C (Nitrile gloves)?

The FDA product code for Examination gloves -Type C (Nitrile gloves) is LZA.

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Other Devices by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

K214017Examination gloves-Type A(Latex gloves) K211953Disposable Sterilized Latex Surgical 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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