Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N

Polymer Patient Examination Glove

Ansell Healthcare Products LLC

The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N.

Pre-market Notification Details

Device IDK210401
510k NumberK210401
Device Name:Microflex Nitrile Patient Examination Gloves Blue Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested For Use With Chemotherapy Drugs And Fentanyl Citrate, Microflex N
ClassificationPolymer Patient Examination Glove
Applicant Ansell Healthcare Products LLC 2301 Robb Drive Reno,  NV  89523
ContactDonald Cronk
CorrespondentDonald Cronk
Ansell Healthcare Products LLC 2301 Robb Drive Reno,  NV  89523
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-06-13

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