Edma Synthetic Nitrile Examination Gloves
K-Number: K211540 · 2021-08-09
ApplicantEdma Group, LLC
Decision Date2021-08-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Edma Synthetic Nitrile Examination Gloves is a medical device manufactured by Edma Group, LLC. It received FDA 510(k) clearance on 2021-08-09 under approval number K211540. 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 Edma Synthetic Nitrile Examination Gloves?
Edma Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-08-09. It is manufactured by Edma Group, LLC. The 510(k) number is K211540.
When was Edma Synthetic Nitrile Examination Gloves approved by the FDA?
Edma Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2021-08-09, under approval number K211540.
What company makes Edma Synthetic Nitrile Examination Gloves?
Edma Synthetic Nitrile Examination Gloves is manufactured by Edma Group, LLC.
What is the FDA product code for Edma Synthetic Nitrile Examination Gloves?
The FDA product code for Edma Synthetic Nitrile Examination Gloves is LZA.
Related Clinical Trials
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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.