Medical Nitrile Examination Gloves (Power free, Blue)
K-Number: K210578 · 2021-07-10
Decision Date2021-07-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medical Nitrile Examination Gloves (Power free, Blue) is a medical device manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-07-10 under approval number K210578. 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 Medical Nitrile Examination Gloves (Power free, Blue)?
Medical Nitrile Examination Gloves (Power free, Blue) is a medical device that received FDA 510(k) clearance on 2021-07-10. It is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K210578.
When was Medical Nitrile Examination Gloves (Power free, Blue) approved by the FDA?
Medical Nitrile Examination Gloves (Power free, Blue) received FDA 510(k) clearance on 2021-07-10, under approval number K210578.
What company makes Medical Nitrile Examination Gloves (Power free, Blue)?
Medical Nitrile Examination Gloves (Power free, Blue) is manufactured by Jiangxi Hongda Medical Equipment Group , Ltd..
What is the FDA product code for Medical Nitrile Examination Gloves (Power free, Blue)?
The FDA product code for Medical Nitrile Examination Gloves (Power free, Blue) is LZA.
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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.