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FDA 510(k)

Disposable Medical Nitrile Examination Gloves

K-Number: K212363 · 2021-10-26

ApplicantLanhuo Medical Technology (Jiangsu) Co.,Ltd
Decision Date2021-10-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves is a medical device manufactured by Lanhuo Medical Technology (Jiangsu) Co.,Ltd. It received FDA 510(k) clearance on 2021-10-26 under approval number K212363. 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 2021-10-26. It is manufactured by Lanhuo Medical Technology (Jiangsu) Co.,Ltd. The 510(k) number is K212363.

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

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2021-10-26, under approval number K212363.

What company makes Disposable Medical Nitrile Examination Gloves?

Disposable Medical Nitrile Examination Gloves is manufactured by Lanhuo Medical Technology (Jiangsu) 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) PMID: 30016835 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel. Final order. Federal register (2018)

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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