NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE

Polymer Patient Examination Glove

TERANG NUSA SDN BHD

The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Nugard Nitril Powderfree Nitrile Examination Glove.

Pre-market Notification Details

Device IDK990840
510k NumberK990840
Device Name:NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
ClassificationPolymer Patient Examination Glove
Applicant TERANG NUSA SDN BHD 1 JALAN 8, PENGKALAN CHEPA 2 INDUSTRIAL ZONE, Kota Bharu, Kelantan,  MY 16100
ContactChin-guan Low
CorrespondentChin-guan Low
TERANG NUSA SDN BHD 1 JALAN 8, PENGKALAN CHEPA 2 INDUSTRIAL ZONE, Kota Bharu, Kelantan,  MY 16100
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-15
Decision Date1999-05-17
Summary:summary

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