Name: Predicase
Price: 199 USD

K-number	K191230
Device name	Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
Applicant	O&M Halyard, Inc.
Product code	LZC
Device class	Class I
Decision date	Nov 8, 2019
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves

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