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FDA 510(k)

Black Pearl Nitrile Examination Glove

K-Number: K232319 · 2024-04-22

ApplicantUg Global Resources Sdn. Bhd.
Decision Date2024-04-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Black Pearl Nitrile Examination Glove is a medical device manufactured by Ug Global Resources Sdn. Bhd.. It received FDA 510(k) clearance on 2024-04-22 under approval number K232319. 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 Black Pearl Nitrile Examination Glove?

Black Pearl Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2024-04-22. It is manufactured by Ug Global Resources Sdn. Bhd.. The 510(k) number is K232319.

When was Black Pearl Nitrile Examination Glove approved by the FDA?

Black Pearl Nitrile Examination Glove received FDA 510(k) clearance on 2024-04-22, under approval number K232319.

What company makes Black Pearl Nitrile Examination Glove?

Black Pearl Nitrile Examination Glove is manufactured by Ug Global Resources Sdn. Bhd..

What is the FDA product code for Black Pearl Nitrile Examination Glove?

The FDA product code for Black Pearl Nitrile Examination Glove is LZA.

Other Devices by Ug Global Resources Sdn. Bhd.

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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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