AMPRI

Latex Patient Examination Glove

AMPRI RUBBERWARE INDUSTRIES SDN BHD

The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Ampri.

Pre-market Notification Details

Device IDK952833
510k NumberK952833
Device Name:AMPRI
ClassificationLatex Patient Examination Glove
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali,  MY
ContactMike Scolari
CorrespondentMike Scolari
AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali,  MY
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-20
Decision Date1995-09-05

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