Name: Predicase
Price: 199 USD

K-number	K200633
Device name	Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
Applicant	0 & M Halyard, Inc.
Product code	LZC
Device class	Class I
Decision date	Oct 11, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove

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