Microflex Nitrile Patient Examination Gloves With Aloe And Chamomile Blue Green Pink Colored Tested For

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 With Aloe And Chamomile Blue Green Pink Colored Tested For.

Pre-market Notification Details

Device IDK200671
510k NumberK200671
Device Name:Microflex Nitrile Patient Examination Gloves With Aloe And Chamomile Blue Green Pink Colored Tested For
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 Received2020-03-13
Decision Date2020-06-19

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.