Iconic Nitrile Glove
K-Number: K212182 · 2021-12-11
ApplicantIconic Medicare Sdn Bhd
Decision Date2021-12-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Iconic Nitrile Glove is a medical device manufactured by Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2021-12-11 under approval number K212182. 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 Iconic Nitrile Glove?
Iconic Nitrile Glove is a medical device that received FDA 510(k) clearance on 2021-12-11. It is manufactured by Iconic Medicare Sdn Bhd. The 510(k) number is K212182.
When was Iconic Nitrile Glove approved by the FDA?
Iconic Nitrile Glove received FDA 510(k) clearance on 2021-12-11, under approval number K212182.
What company makes Iconic Nitrile Glove?
Iconic Nitrile Glove is manufactured by Iconic Medicare Sdn Bhd.
What is the FDA product code for Iconic Nitrile Glove?
The FDA product code for Iconic Nitrile Glove is LZA.
Other Devices by Iconic Medicare 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.