Medical nitrile examination gloves (Model: JL001)
K-Number: K213848 · 2022-03-25
Decision Date2022-03-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medical nitrile examination gloves (Model: JL001) is a medical device manufactured by Guangdong Jiali Pharmaceutical Co.,Ltd. It received FDA 510(k) clearance on 2022-03-25 under approval number K213848. 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 (Model: JL001)?
Medical nitrile examination gloves (Model: JL001) is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Guangdong Jiali Pharmaceutical Co.,Ltd. The 510(k) number is K213848.
When was Medical nitrile examination gloves (Model: JL001) approved by the FDA?
Medical nitrile examination gloves (Model: JL001) received FDA 510(k) clearance on 2022-03-25, under approval number K213848.
What company makes Medical nitrile examination gloves (Model: JL001)?
Medical nitrile examination gloves (Model: JL001) is manufactured by Guangdong Jiali Pharmaceutical Co.,Ltd.
What is the FDA product code for Medical nitrile examination gloves (Model: JL001)?
The FDA product code for Medical nitrile examination gloves (Model: JL001) 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.