NITRILE POWDER-FREE EXAMINATION GLOVES

Polymer Patient Examination Glove

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Nitrile Powder-free Examination Gloves.

Pre-market Notification Details

Device IDK022765
510k NumberK022765
Device Name:NITRILE POWDER-FREE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park,  IL  60085
ContactErica Sethi
CorrespondentErica Sethi
ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park,  IL  60085
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-20
Decision Date2002-10-11
Summary:summary

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