ARISTA VINYL EXAMINATION GLOVES

Vinyl 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 Arista Vinyl Examination Gloves.

Pre-market Notification Details

Device IDK954153
510k NumberK954153
Device Name:ARISTA VINYL EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
ContactLinga Sumarta
CorrespondentLinga Sumarta
ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta,  ID 11210
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-05
Decision Date1996-01-26

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