POWDER FREE LATEX EXAMINATION GLOVES

Latex Patient Examination Glove

KHAI HOAN JOINT STOCK COMPANY

The following data is part of a premarket notification filed by Khai Hoan Joint Stock Company with the FDA for Powder Free Latex Examination Gloves.

Pre-market Notification Details

Device IDK113685
510k NumberK113685
Device Name:POWDER FREE LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province,  VN Vm
ContactTerence Lim
CorrespondentTerence Lim
KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT Binh Duong Province,  VN Vm
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-15
Decision Date2012-08-10

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