POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS

Latex Patient Examination Glove

HARTALEGA SDN BHD

The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powdered Latex Examination Gloves With Protein Content Labeling Claim Of 200 Micrograms Or Less.

Pre-market Notification Details

Device IDK993760
510k NumberK993760
Device Name:POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
ClassificationLatex Patient Examination Glove
Applicant HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
ContactKuan Kam Hon
CorrespondentKuan Kam Hon
HARTALEGA SDN BHD 9 JALAN KUANG BULAN TAMAN KEPONG INDUSTRIAL ESTATE Kuala Lumpur,  MY 52100
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-08
Decision Date2000-05-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.