ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES

Polymer Patient Examination Glove

NORTHSTAR HEALTHCARE HOLDINGS

The following data is part of a premarket notification filed by Northstar Healthcare Holdings with the FDA for Ets Blue Powder-free Patient Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK121947
510k NumberK121947
Device Name:ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant NORTHSTAR HEALTHCARE HOLDINGS HAMILTON HOUSE, 10 QUEEN ST Hamilton, Bermuda,  IE Hm11
ContactWesley Toavs
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-07-03
Decision Date2012-09-10
Summary:summary

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