ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES

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 Absogel Sterile Powder-free Surgical Gloves.

Pre-market Notification Details

Device IDK945948
510k NumberK945948
Device Name:ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES
ClassificationSurgeon's Gloves
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD MIEL PHASE II 44300 BATANG KALI Selangor,  MY
ContactMay Phng
CorrespondentMay Phng
AMPRI RUBBERWARE INDUSTRIES SDN BHD MIEL PHASE II 44300 BATANG KALI Selangor,  MY
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-06
Decision Date1995-07-31

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