K-number	K211540
Device name	Edma Synthetic Nitrile Examination Gloves
Applicant	Edma Group, LLC
Product code	LZA
Device class	Class I
Decision date	Aug 9, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Edma Synthetic Nitrile Examination Gloves

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