ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA

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 Encore Acclaim Sterile Powder-free Latex Surgical Gloves, Tested For Use With Chemothera.

Pre-market Notification Details

Device IDK103714
510k NumberK103714
Device Name:ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
ClassificationSurgeon's Gloves
Applicant ANSELL HEALTHCARE PRODUCTS, LLC 555 ZANG STREET, SUITE 100 Lakewood,  CO  80228
ContactMary L Armstrong
CorrespondentMary L Armstrong
ANSELL HEALTHCARE PRODUCTS, LLC 555 ZANG STREET, SUITE 100 Lakewood,  CO  80228
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-21
Decision Date2011-07-07
Summary:summary

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