Decision Date2023-06-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
APOLLO ADVANTAGE Nitrile Examination Gloves is a medical device manufactured by Dell Corning Corporation. It received FDA 510(k) clearance on 2023-06-05 under approval number K230633. 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 APOLLO ADVANTAGE Nitrile Examination Gloves?
APOLLO ADVANTAGE Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Dell Corning Corporation. The 510(k) number is K230633.
When was APOLLO ADVANTAGE Nitrile Examination Gloves approved by the FDA?
APOLLO ADVANTAGE Nitrile Examination Gloves received FDA 510(k) clearance on 2023-06-05, under approval number K230633.
What company makes APOLLO ADVANTAGE Nitrile Examination Gloves?
APOLLO ADVANTAGE Nitrile Examination Gloves is manufactured by Dell Corning Corporation.
What is the FDA product code for APOLLO ADVANTAGE Nitrile Examination Gloves?
The FDA product code for APOLLO ADVANTAGE Nitrile Examination Gloves is 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.