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FDA 510(k)

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves

K-Number: K212349 · 2021-12-10

ApplicantMedi Legion Sdn.Bhd
Decision Date2021-12-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves is a medical device manufactured by Medi Legion Sdn.Bhd. It received FDA 510(k) clearance on 2021-12-10 under approval number K212349. 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, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves?

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Medi Legion Sdn.Bhd. The 510(k) number is K212349.

When was Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves approved by the FDA?

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves received FDA 510(k) clearance on 2021-12-10, under approval number K212349.

What company makes Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves?

Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves is manufactured by Medi Legion Sdn.Bhd.

What is the FDA product code for Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves?

The FDA product code for Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves 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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