Cardinal Health Protexis PI Blue With Neu-Thera Surgical Glove

Surgeon's Gloves

Cardinal Health 200, LLC

The following data is part of a premarket notification filed by Cardinal Health 200, Llc with the FDA for Cardinal Health Protexis Pi Blue With Neu-thera Surgical Glove.

Pre-market Notification Details

Device IDK201592
510k NumberK201592
Device Name:Cardinal Health Protexis PI Blue With Neu-Thera Surgical Glove
ClassificationSurgeon's Gloves
Applicant Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
ContactPadmini Sahoo
CorrespondentPadmini Sahoo
Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan,  IL  60085
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-12
Decision Date2021-09-26

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