Name: Predicase
Price: 199 USD

K-number	K190876
Device name	mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Applicant	Mercator Medical (Thailand), Ltd.
Product code	LZA
Device class	Class I
Decision date	Dec 2, 2019
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

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