PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE

Surgeon's Gloves

TILLOTSON HEALTHCARE CORP.

The following data is part of a premarket notification filed by Tillotson Healthcare Corp. with the FDA for Pure Advantage Nitrile Hypoallergenic Surgical Glove.

Pre-market Notification Details

Device IDK972009
510k NumberK972009
Device Name:PURE ADVANTAGE NITRILE HYPOALLERGENIC SURGICAL GLOVE
ClassificationSurgeon's Gloves
Applicant TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110
ContactEdward Markovic
CorrespondentEdward Markovic
TILLOTSON HEALTHCARE CORP. 360 ROUTE 101 Bedford,  NH  03110
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-30
Decision Date1997-09-12
Summary:summary

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