Name: Predicase
Price: 199 USD

K-number	K182096
Device name	Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Applicant	Owens & Minor Halyard, Inc.
Product code	LZA
Device class	Class I
Decision date	Nov 2, 2018
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

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