NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE

Polymer Patient Examination Glove

ANSELL EDMONT INDUSTRIAL, INC.

The following data is part of a premarket notification filed by Ansell Edmont Industrial, Inc. with the FDA for Nitra-touch Powder-free Nitrile Medical Examination Glove.

Pre-market Notification Details

Device IDK965095
510k NumberK965095
Device Name:NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
ClassificationPolymer Patient Examination Glove
Applicant ANSELL EDMONT INDUSTRIAL, INC. 1300 WALNUT ST. Coshocton,  OH  43812
ContactMike W Hagans
CorrespondentMike W Hagans
ANSELL EDMONT INDUSTRIAL, INC. 1300 WALNUT ST. Coshocton,  OH  43812
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-19
Decision Date1997-04-22
Summary:summary

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