ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

Latex Patient Examination Glove

TILLOTSON HEALTHCARE CORP.

The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Ultra Care 2 Latex Examination Gloves Made From Allotex (enzyme Treated) Natural Rubber Latex With A Protein Content Lab.

Pre-market Notification Details

Device IDK002718
510k NumberK002718
Device Name:ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
ClassificationLatex Patient Examination Glove
Applicant TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110 -5030
ContactF.w. Perrella
CorrespondentF.w. Perrella
TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110 -5030
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-31
Decision Date2001-05-01

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