FDA.reportPublic FDA data

Device Listing 1201759637

Listing Summary#

Listing key
1201759637
Premarket submission
K213289
Device
Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
Applicant
Ansell Healthcare Products, LLC
Product code
KGO
Decision date
2023-05-26