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FDA 510(k)

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)

K-Number: K233182 · 2023-12-15

ApplicantZibo Kaiyue Mould Technology Co., Ltd.
Decision Date2023-12-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) is a medical device manufactured by Zibo Kaiyue Mould Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under approval number K233182. 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 Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Zibo Kaiyue Mould Technology Co., Ltd.. The 510(k) number is K233182.

When was Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) approved by the FDA?

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) received FDA 510(k) clearance on 2023-12-15, under approval number K233182.

What company makes Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)?

Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) is manufactured by Zibo Kaiyue Mould Technology Co., Ltd..

What is the FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)?

The FDA product code for Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) is LZA.

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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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