Decision Date2021-10-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ZinRom Nitrile examination gloves is a medical device manufactured by Changzhou Xingrong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-06 under approval number K211719. 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 ZinRom Nitrile examination gloves?
ZinRom Nitrile examination gloves is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Changzhou Xingrong Medical Technology Co., Ltd.. The 510(k) number is K211719.
When was ZinRom Nitrile examination gloves approved by the FDA?
ZinRom Nitrile examination gloves received FDA 510(k) clearance on 2021-10-06, under approval number K211719.
What company makes ZinRom Nitrile examination gloves?
ZinRom Nitrile examination gloves is manufactured by Changzhou Xingrong Medical Technology Co., Ltd..
What is the FDA product code for ZinRom Nitrile examination gloves?
The FDA product code for ZinRom 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.