Decision Date2022-05-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Powder Free Examination Gloves is a medical device manufactured by Hebei Kangxida Medical Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-05-18 under approval number K220211. 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 Nitrile Powder Free Examination Gloves?
Nitrile Powder Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by Hebei Kangxida Medical Technology Development Co., Ltd.. The 510(k) number is K220211.
When was Nitrile Powder Free Examination Gloves approved by the FDA?
Nitrile Powder Free Examination Gloves received FDA 510(k) clearance on 2022-05-18, under approval number K220211.
What company makes Nitrile Powder Free Examination Gloves?
Nitrile Powder Free Examination Gloves is manufactured by Hebei Kangxida Medical Technology Development Co., Ltd..
What is the FDA product code for Nitrile Powder Free Examination Gloves?
The FDA product code for Nitrile Powder Free 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.