SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2

Surgeon's Gloves

TERANG NUSA SDN BHD

The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Synthetic Surgical Glove-powderfree Nuzone X2.

Pre-market Notification Details

Device IDK041436
510k NumberK041436
Device Name:SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
ClassificationSurgeon's Gloves
Applicant TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan,  MY 16100
ContactChin-guan Low
CorrespondentChin-guan Low
TERANG NUSA SDN BHD 1, JALAN 8, PENGKALAN CHEPA 2 IND. ZONE Kota Bharu, Kelantan,  MY 16100
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-28
Decision Date2004-08-20
Summary:summary

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