CORRECT TOUCH SURGEONS 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 Correct Touch Surgeons Gloves.

Pre-market Notification Details

Device IDK892176
510k NumberK892176
Device Name:CORRECT TOUCH SURGEONS GLOVES
ClassificationSurgeon's Gloves
Applicant AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia,  MY
ContactMay Phng
CorrespondentMay Phng
AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia,  MY
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-05
Decision Date1989-09-06

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