Decision Date2021-12-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Examination Golves Powder Free is a medical device manufactured by Jiangsu Standard Health Co.,Ltd. It received FDA 510(k) clearance on 2021-12-24 under approval number K212921. 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 Examination Golves Powder Free?
Nitrile Examination Golves Powder Free is a medical device that received FDA 510(k) clearance on 2021-12-24. It is manufactured by Jiangsu Standard Health Co.,Ltd. The 510(k) number is K212921.
When was Nitrile Examination Golves Powder Free approved by the FDA?
Nitrile Examination Golves Powder Free received FDA 510(k) clearance on 2021-12-24, under approval number K212921.
What company makes Nitrile Examination Golves Powder Free?
Nitrile Examination Golves Powder Free is manufactured by Jiangsu Standard Health Co.,Ltd.
What is the FDA product code for Nitrile Examination Golves Powder Free?
The FDA product code for Nitrile Examination Golves Powder Free 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.