AMPRI

Surgeon's Gloves

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 IDK954002
510k NumberK954002
Device Name:AMPRI
ClassificationSurgeon's Gloves
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor,  MY
ContactMay Phng
CorrespondentMay Phng
AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor,  MY
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-25
Decision Date1996-01-29

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