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FDA 510(k)

Medical Nitrile Examination Gloves

K-Number: K212014 · 2021-10-13

ApplicantJiangxi Ronglai Medical Technology Co., Ltd.
Decision Date2021-10-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Nitrile Examination Gloves is a medical device manufactured by Jiangxi Ronglai Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-13 under approval number K212014. 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 Medical Nitrile Examination Gloves?

Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Jiangxi Ronglai Medical Technology Co., Ltd.. The 510(k) number is K212014.

When was Medical Nitrile Examination Gloves approved by the FDA?

Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2021-10-13, under approval number K212014.

What company makes Medical Nitrile Examination Gloves?

Medical Nitrile Examination Gloves is manufactured by Jiangxi Ronglai Medical Technology Co., Ltd..

What is the FDA product code for Medical Nitrile Examination Gloves?

The FDA product code for Medical Nitrile Examination Gloves is LZA.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

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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