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FDA 510(k)

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

K-Number: K222498 · 2022-10-26

ApplicantHumanwell Healthcare Group Medical Supplies Co., Ltd.
Decision Date2022-10-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is a medical device manufactured by Humanwell Healthcare Group Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2022-10-26 under approval number K222498. 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 Examination Gloves (Nitrile) (XS, S, M, L, XL)?

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Humanwell Healthcare Group Medical Supplies Co., Ltd.. The 510(k) number is K222498.

When was Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) approved by the FDA?

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) received FDA 510(k) clearance on 2022-10-26, under approval number K222498.

What company makes Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)?

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) is manufactured by Humanwell Healthcare Group Medical Supplies Co., Ltd..

What is the FDA product code for Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)?

The FDA product code for Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) 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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