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FDA 510(k)

Disposable Medical Nitrile Examination Gloves

K-Number: K220561 · 2022-04-14

ApplicantNanjing Universal Medical Equipment Co., Ltd.
Decision Date2022-04-14
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves is a medical device manufactured by Nanjing Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-04-14 under approval number K220561. 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 Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-04-14. It is manufactured by Nanjing Universal Medical Equipment Co., Ltd.. The 510(k) number is K220561.

When was Disposable Medical Nitrile Examination Gloves approved by the FDA?

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2022-04-14, under approval number K220561.

What company makes Disposable Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is manufactured by Nanjing Universal Medical Equipment Co., Ltd..

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

The FDA product code for Disposable 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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