AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM

Latex Patient Examination Glove

SUPERMAX GLOVE MANUFACTURING SDN BHD

The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Aurelia Chlorinated Powder Free Latex Medical Examination Gloves With Aloe Vera And Ginseng With Protein Labeling Claim.

Pre-market Notification Details

Device IDK013953
510k NumberK013953
Device Name:AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
ClassificationLatex Patient Examination Glove
Applicant SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor,  MY 47000
ContactStanley Thai
CorrespondentStanley Thai
SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor,  MY 47000
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-11-30
Decision Date2002-02-26

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