BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES

Polymer Patient Examination Glove

ETHICON ENDO-SURGERY, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Blue Colour Powder Free Barrierpro Polymer Bp2000 Polybutadiene Copolymer Examination Gloves.

Pre-market Notification Details

Device IDK061192
510k NumberK061192
Device Name:BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
ContactElizabeth Miller,mst
CorrespondentElizabeth Miller,mst
ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati,  OH  45242
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-28
Decision Date2006-05-23
Summary:summary

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