FDA 510(k) Application Details - K032938

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K032938
Device Name	Latex Patient Examination Glove
Applicant	BRIGHTWAY HOLDINGS SDN. BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH KLANG, SELANGOR 42100 MY Other 510(k) Applications for this Company
Contact	G. BASKARAN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2003
Decision Date	11/20/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review