UNISEAL GLOVES LOW PROTEIN POWDERED

Latex Patient Examination Glove

AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by American Healthcare Products (m) Sdn Bhd with the FDA for Uniseal Gloves Low Protein Powdered.

Pre-market Notification Details

Device IDK981979
510k NumberK981979
Device Name:UNISEAL GLOVES LOW PROTEIN POWDERED
ClassificationLatex Patient Examination Glove
Applicant AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800,  MY 71800
ContactTarani Devi
CorrespondentTarani Devi
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD PT 7521 TAMAN SEMARAK II LIGHT INDUSTRIAL PARK Nilai, Negeri Sembilan 71800,  MY 71800
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-05
Decision Date1998-11-30

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