POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES

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 Powder Free Green, Blue And Brown Polychloroprene Examination Gloves.

Pre-market Notification Details

Device IDK133699
510k NumberK133699
Device Name:POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant PT. SMART GLOVE INDONESIA JL. PELITA RAUYA NO. 5-7,KIM STAR, TANJUNG MORAWA Medan, North Sumater,  ID 20362
ContactKhon Pu Foo
CorrespondentKhon Pu Foo
PT. SMART GLOVE INDONESIA JL. PELITA RAUYA NO. 5-7,KIM STAR, TANJUNG MORAWA Medan, North Sumater,  ID 20362
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-03
Decision Date2014-07-18
Summary:summary

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