BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES

Surgeon's Gloves

MOLNLYCKE HEALTH CARE US, LLC

The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Ps Surgical Glove Series, Biogel Skinsense Surgical Glove Series.

Pre-market Notification Details

Device IDK140477
510k NumberK140477
Device Name:BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
ClassificationSurgeon's Gloves
Applicant MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
ContactCurtis D Truesdale
CorrespondentCurtis D Truesdale
MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross,  GA  30092
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-26
Decision Date2015-03-23
Summary:summary

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