Name: Predicase
Price: 199 USD

K-number	K220547
Device name	PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
Applicant	O&M Halyard, Inc.
Product code	LZA
Device class	Class I
Decision date	Jun 2, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

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