Name: Predicase
Price: 199 USD

K-number	K213600
Device name	Medical nitrile examination gloves (Model: SH001)
Applicant	Jiangxi Sanhao Medical Instruments Co.,Ltd
Product code	LZA
Device class	Class I
Decision date	Feb 19, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Medical nitrile examination gloves (Model: SH001)

Everything you need for a 510(k) submission. Nothing you don't.