Name: Predicase
Price: 199 USD

K-number	K190725
Device name	Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Applicant	Riverstone Resources Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Dec 17, 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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Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

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