POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK

Polymer Patient Examination Glove

PT. MEDISAFE TECHNOLOGIES

The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powder Free Polychloroprene Light Wieght Examinationgloves- Green,blue And Pink.

Pre-market Notification Details

Device IDK133689
510k NumberK133689
Device Name:POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
ClassificationPolymer Patient Examination Glove
Applicant PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA Medan, North Sumatera,  ID 20362
ContactAnil Taneja
CorrespondentAnil Taneja
PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA Medan, North Sumatera,  ID 20362
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-02
Decision Date2014-07-03
Summary:summary

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