Name: Predicase
Price: 199 USD

K-number	K170290
Device name	Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
Applicant	Shen Wei USA, Inc.
Product code	LZA
Device class	Class I
Decision date	May 24, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr

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