POWDERED GREEN LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

SRI JOHANI SDN. BHD.

The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for Powdered Green Latex Examination Gloves.

Pre-market Notification Details

Device IDK980039
510k NumberK980039
Device Name:POWDERED GREEN LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor,  MY 43300
ContactLim L Aik
CorrespondentLim L Aik
SRI JOHANI SDN. BHD. LOT PT 7178, BALAKONG N/V, SERI KEMBANGAN Selangor,  MY 43300
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-05
Decision Date1998-02-09

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