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FDA 510(k)

Nitrile Medical Examination Gloves

K-Number: K221108 · 2022-07-12

ApplicantAnhui Fulewei Electronic Technology Co.,Ltd
Decision Date2022-07-12
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Medical Examination Gloves is a medical device manufactured by Anhui Fulewei Electronic Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-07-12 under approval number K221108. 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 Nitrile Medical Examination Gloves?

Nitrile Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-07-12. It is manufactured by Anhui Fulewei Electronic Technology Co.,Ltd. The 510(k) number is K221108.

When was Nitrile Medical Examination Gloves approved by the FDA?

Nitrile Medical Examination Gloves received FDA 510(k) clearance on 2022-07-12, under approval number K221108.

What company makes Nitrile Medical Examination Gloves?

Nitrile Medical Examination Gloves is manufactured by Anhui Fulewei Electronic Technology Co.,Ltd.

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

The FDA product code for Nitrile Medical 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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