Name: Predicase
Price: 199 USD

K-number	K171737
Device name	Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Applicant	Ansell Healthcare Products, LLC
Product code	LZA
Device class	Class I
Decision date	Dec 29, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves

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