MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)

Polymer Patient Examination Glove

ANSELL HEALTHCARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Ansell Healthcare Products, Inc. with the FDA for Micro-touch Nitratex Sterile Nitrile Powder-free Blue Examination Gloves (chemotherapy Use).

Pre-market Notification Details

Device IDK082457
510k NumberK082457
Device Name:MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
ClassificationPolymer Patient Examination Glove
Applicant ANSELL HEALTHCARE PRODUCTS, INC. 1635 INDUSTRIAL ROAD Dothan,  AL  36303
ContactCynthia A Ingram
CorrespondentCynthia A Ingram
ANSELL HEALTHCARE PRODUCTS, INC. 1635 INDUSTRIAL ROAD Dothan,  AL  36303
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-26
Decision Date2008-11-10
Summary:summary

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