ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE

Surgeon's Gloves

ANSELL PERRY

The following data is part of a premarket notification filed by Ansell Perry with the FDA for Elite Mark Iv Powder Free Polyurethane Synthetic Surgical Glove.

Pre-market Notification Details

Device IDK981392
510k NumberK981392
Device Name:ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
ClassificationSurgeon's Gloves
Applicant ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
ContactJames R Chatterton
CorrespondentJames R Chatterton
ANSELL PERRY 1875 HARSH AVE. S.E. Massillon,  OH  44646 -7199
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-17
Decision Date1998-05-11
Summary:summary

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