Name: Predicase
Price: 199 USD

K-number	K161473
Device name	Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
Applicant	Medline Industries, Inc.
Product code	LZA
Device class	Class I
Decision date	Oct 19, 2016
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)

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