LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING

Patient Examination Glove, Specialty

Cardinal Health

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Latex Powder-free Examination Gloves With Coating.

Pre-market Notification Details

Device IDK033789
510k NumberK033789
Device Name:LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
ClassificationPatient Examination Glove, Specialty
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 CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-04
Decision Date2004-05-07
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.