Gammex Cut-Resistant Glove Liner

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 Cut-resistant Glove Liner.

Pre-market Notification Details

Device IDK160974
510k NumberK160974
Device Name:Gammex Cut-Resistant Glove Liner
ClassificationSurgeon's Gloves
Applicant ANSELL HEALTHCARE PRODUCTS LLC 111 WOOD AVENUE SOUTH SUITE 210 Iselin,  NJ  08830
ContactRobert Mahler
CorrespondentRobert Mahler
ANSELL HEALTHCARE PRODUCTS LLC 111 WOOD AVENUE SOUTH SUITE 210 Iselin,  NJ  08830
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-07
Decision Date2016-10-28
Summary:summary

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