ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES

Surgeon's Gloves

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Esteem Sterile Polyisoprene Surgical Gloves.

Pre-market Notification Details

Device IDK011721
510k NumberK011721
Device Name:ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
ContactErica Sethi
CorrespondentErica Sethi
ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park,  IL  60085
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-04
Decision Date2001-08-14
Summary:summary

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