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FDA 510(k)

Disposable Medical Examination Nitrile Gloves

K-Number: K232008 · 2023-08-08

ApplicantRaxwell Industrial, LLC
Decision Date2023-08-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Examination Nitrile Gloves is a medical device manufactured by Raxwell Industrial, LLC. It received FDA 510(k) clearance on 2023-08-08 under approval number K232008. 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 Examination Nitrile Gloves?

Disposable Medical Examination Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Raxwell Industrial, LLC. The 510(k) number is K232008.

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

Disposable Medical Examination Nitrile Gloves received FDA 510(k) clearance on 2023-08-08, under approval number K232008.

What company makes Disposable Medical Examination Nitrile Gloves?

Disposable Medical Examination Nitrile Gloves is manufactured by Raxwell Industrial, LLC.

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

The FDA product code for Disposable Medical Examination Nitrile 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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