ABSOGEL CHEMOTHERAPHY GLOVES

Patient Examination Glove, Specialty

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 Absogel Chemotheraphy Gloves.

Pre-market Notification Details

Device IDK990677
510k NumberK990677
Device Name:ABSOGEL CHEMOTHERAPHY GLOVES
ClassificationPatient Examination Glove, Specialty
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor,  MY 44300
ContactLi Kim Phng
CorrespondentLi Kim Phng
AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor,  MY 44300
Product CodeLZC  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-02
Decision Date1999-11-01

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.