K-number	K211547
Device name	Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Applicant	Edma Group, LLC
Product code	LZA
Device class	Class I
Decision date	Jul 15, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)

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