ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

Surgeon's Gloves

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Esteem Sterile Polyisoprene Surgical Gloves With Coating.

Pre-market Notification Details

Device IDK031301
510k NumberK031301
Device Name:ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
ClassificationSurgeon's Gloves
Applicant Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park,  IL  60085
ContactErica Sethi
CorrespondentErica Sethi
Cardinal Health 1500 WAUKEGAN RD. BLDG. WM Mcgaw Park,  IL  60085
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-24
Decision Date2003-10-15
Summary:summary

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