POWDERFREE NATURAL LATEX GLOVES

Latex Patient Examination Glove

ARISTA LATINDO INDUSTRIAL LTD. P.T

The following data is part of a premarket notification filed by Arista Latindo Industrial Ltd. P.t with the FDA for Powderfree Natural Latex Gloves.

Pre-market Notification Details

Device IDK921389
510k NumberK921389
Device Name:POWDERFREE NATURAL LATEX GLOVES
ClassificationLatex Patient Examination Glove
Applicant ARISTA LATINDO INDUSTRIAL LTD. P.T P.O. BOX 1129 JAKARTA Indonesia,  ID
ContactGentho Sumarta
CorrespondentGentho Sumarta
ARISTA LATINDO INDUSTRIAL LTD. P.T P.O. BOX 1129 JAKARTA Indonesia,  ID
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-23
Decision Date1993-08-05

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