POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE

Latex Patient Examination Glove

KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

The following data is part of a premarket notification filed by Kossan Latex Industries (m) Sdn. Bhd. with the FDA for Polymer Coated, Powder-free Latex Examination Glove Contains 50 Micrograms Or Less Of Total Water Extractable Protein Pe.

Pre-market Notification Details

Device IDK001190
510k NumberK001190
Device Name:POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
ClassificationLatex Patient Examination Glove
Applicant KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor,  MY 41050
ContactLim Kwan Hwa
CorrespondentLim Kwan Hwa
KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor,  MY 41050
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-12
Decision Date2000-05-23

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