TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE

Polymer Patient Examination Glove

TILLOTSON HEALTHCARE CORP.

The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for True Advantage Non-sterile Powder Free Purple Nitrile Examination Glove.

Pre-market Notification Details

Device IDK013016
510k NumberK013016
Device Name:TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
ClassificationPolymer Patient Examination Glove
Applicant TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110
ContactF. W Perrella
CorrespondentF. W Perrella
TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-07
Decision Date2001-10-19
Summary:summary

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