Edma Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

Edma Group, LLC

The following data is part of a premarket notification filed by Edma Group, Llc with the FDA for Edma Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK211547
510k NumberK211547
Device Name:Edma Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Edma Group, LLC 3634 E Piccadilly Rd Phoenix,  AZ  85018
ContactVio Cretu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161 Lujiazui East Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-07-15

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