Medical nitrile examination gloves (Model: SH001)
K-Number: K213600 · 2022-02-19
Decision Date2022-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Medical nitrile examination gloves (Model: SH001) is a medical device manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-02-19 under approval number K213600. 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: SH001)?
Medical nitrile examination gloves (Model: SH001) is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd. The 510(k) number is K213600.
When was Medical nitrile examination gloves (Model: SH001) approved by the FDA?
Medical nitrile examination gloves (Model: SH001) received FDA 510(k) clearance on 2022-02-19, under approval number K213600.
What company makes Medical nitrile examination gloves (Model: SH001)?
Medical nitrile examination gloves (Model: SH001) is manufactured by Jiangxi Sanhao Medical Instruments Co.,Ltd.
What is the FDA product code for Medical nitrile examination gloves (Model: SH001)?
The FDA product code for Medical nitrile examination gloves (Model: SH001) is LZA.
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Official Source
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