POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE

Latex Patient Examination Glove

NORTHSTAR HEALTHCARE HOLDINGS LIMITED

The following data is part of a premarket notification filed by Northstar Healthcare Holdings Limited with the FDA for Powder Free Latex Patient Exam Glove With Protein Labeling Claim (50 Micrograms Per Dm Squared Or Less Of Water Soluble.

Pre-market Notification Details

Device IDK112988
510k NumberK112988
Device Name:POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
ClassificationLatex Patient Examination Glove
Applicant NORTHSTAR HEALTHCARE HOLDINGS LIMITED 1202 SOUTH ROUTE 31 Mchenry,  IL  60050
ContactAntonio L Giaccio
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-10-06
Decision Date2011-11-09
Summary:summary

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