Disposable Medical Nitrile Examination Gloves (Non-sterile)
K-Number: K212600 · 2021-11-18
Decision Date2021-11-18
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Medical Nitrile Examination Gloves (Non-sterile) is a medical device manufactured by Suqian Linglian Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under approval number K212600. 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 Disposable Medical Nitrile Examination Gloves (Non-sterile)?
Disposable Medical Nitrile Examination Gloves (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Suqian Linglian Medical Technology Co., Ltd.. The 510(k) number is K212600.
When was Disposable Medical Nitrile Examination Gloves (Non-sterile) approved by the FDA?
Disposable Medical Nitrile Examination Gloves (Non-sterile) received FDA 510(k) clearance on 2021-11-18, under approval number K212600.
What company makes Disposable Medical Nitrile Examination Gloves (Non-sterile)?
Disposable Medical Nitrile Examination Gloves (Non-sterile) is manufactured by Suqian Linglian Medical Technology Co., Ltd..
What is the FDA product code for Disposable Medical Nitrile Examination Gloves (Non-sterile)?
The FDA product code for Disposable Medical Nitrile Examination Gloves (Non-sterile) 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.