Gammex PI Hybrid Surgical Gloves Tested For Use With Chemotherapy Drugs

Surgeon's Gloves

Ansell Healthcare Products, LLC.

The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc. with the FDA for Gammex Pi Hybrid Surgical Gloves Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK182948
510k NumberK182948
Device Name:Gammex PI Hybrid Surgical Gloves Tested For Use With Chemotherapy Drugs
ClassificationSurgeon's Gloves
Applicant Ansell Healthcare Products, LLC. 2301 Robb Drive Reno,  NV  89523
ContactDon Cronk
CorrespondentDon Cronk
Ansell Healthcare Products, LLC. 2301 Robb Drive Reno,  NV  89523
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-23
Decision Date2019-03-22

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