POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR

Polymer Patient Examination Glove

PT. SMART GLOVE INDONESIA

The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Polymer Coat Powder Free Nitrile Examination Gloves, Green And White Color.

Pre-market Notification Details

Device IDK041848
510k NumberK041848
Device Name:POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
ClassificationPolymer Patient Examination Glove
Applicant PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR JL RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang,  ID 20362
ContactFoo Khon Pu
CorrespondentFoo Khon Pu
PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR JL RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang,  ID 20362
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-08
Decision Date2004-08-20

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