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FDA 510(k)

Powder Free Blue Nitrile Examination Gloves

K-Number: K213678 · 2022-03-22

ApplicantLienteh Technology Sdn Bhd
Decision Date2022-03-22
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Blue Nitrile Examination Gloves is a medical device manufactured by Lienteh Technology Sdn Bhd. It received FDA 510(k) clearance on 2022-03-22 under approval number K213678. 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 Blue Nitrile Examination Gloves?

Powder Free Blue Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Lienteh Technology Sdn Bhd. The 510(k) number is K213678.

When was Powder Free Blue Nitrile Examination Gloves approved by the FDA?

Powder Free Blue Nitrile Examination Gloves received FDA 510(k) clearance on 2022-03-22, under approval number K213678.

What company makes Powder Free Blue Nitrile Examination Gloves?

Powder Free Blue Nitrile Examination Gloves is manufactured by Lienteh Technology Sdn Bhd.

What is the FDA product code for Powder Free Blue Nitrile Examination Gloves?

The FDA product code for Powder Free Blue Nitrile Examination Gloves is LZA.

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Related Devices (Code: LZA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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