POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

Latex Patient Examination Glove

YTY INDUSTRY (MANJUNG) SDN. BHD.

The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Powdered Natural And/or Colored Latex Exam Gloves.

Pre-market Notification Details

Device IDK023590
510k NumberK023590
Device Name:POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
ClassificationLatex Patient Examination Glove
Applicant YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
ContactJanna P Tucker
CorrespondentJanna P Tucker
YTY INDUSTRY (MANJUNG) SDN. BHD. 198 AVENUE DE LA D'EMERALD Sparks,  NV  89434 -9550
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-25
Decision Date2002-11-08
Summary:summary

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