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FDA 510(k)

UniTex Non-Sterile, Powder-Free, Latex Examination Glove

K-Number: K161961 · 2017-05-11

ApplicantUg Global Resources Sdn. Bhd.
Decision Date2017-05-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UniTex Non-Sterile, Powder-Free, Latex Examination Glove is a medical device manufactured by Ug Global Resources Sdn. Bhd.. It received FDA 510(k) clearance on 2017-05-11 under approval number K161961. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

UniTex Non-Sterile, Powder-Free, Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Ug Global Resources Sdn. Bhd.. The 510(k) number is K161961.

When was UniTex Non-Sterile, Powder-Free, Latex Examination Glove approved by the FDA?

UniTex Non-Sterile, Powder-Free, Latex Examination Glove received FDA 510(k) clearance on 2017-05-11, under approval number K161961.

What company makes UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

UniTex Non-Sterile, Powder-Free, Latex Examination Glove is manufactured by Ug Global Resources Sdn. Bhd..

What is the FDA product code for UniTex Non-Sterile, Powder-Free, Latex Examination Glove?

The FDA product code for UniTex Non-Sterile, Powder-Free, Latex Examination Glove is LYY.

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Other Devices by Ug Global Resources Sdn. Bhd.

K162510Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue K232319Black Pearl Nitrile Examination Glove

Related Devices (Code: LYY)

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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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