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FDA 510(k)

Synthetic Polymer Glove - Polyethylene (Black)

K-Number: K222531 · 2023-01-22

ApplicantUr Industry Sdn Bhd
Decision Date2023-01-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthetic Polymer Glove - Polyethylene (Black) is a medical device manufactured by Ur Industry Sdn Bhd. It received FDA 510(k) clearance on 2023-01-22 under approval number K222531. 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 Synthetic Polymer Glove - Polyethylene (Black)?

Synthetic Polymer Glove - Polyethylene (Black) is a medical device that received FDA 510(k) clearance on 2023-01-22. It is manufactured by Ur Industry Sdn Bhd. The 510(k) number is K222531.

When was Synthetic Polymer Glove - Polyethylene (Black) approved by the FDA?

Synthetic Polymer Glove - Polyethylene (Black) received FDA 510(k) clearance on 2023-01-22, under approval number K222531.

What company makes Synthetic Polymer Glove - Polyethylene (Black)?

Synthetic Polymer Glove - Polyethylene (Black) is manufactured by Ur Industry Sdn Bhd.

What is the FDA product code for Synthetic Polymer Glove - Polyethylene (Black)?

The FDA product code for Synthetic Polymer Glove - Polyethylene (Black) is 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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