Name: Predicase
Price: 199 USD

K-number	K162924
Device name	Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
Applicant	Hartalega Sdb. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jan 24, 2017
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 Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)

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