FDA 510(k) Application Details - K033532

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K033532
Device Name	Latex Patient Examination Glove
Applicant	ASIA PACIFIC LATEX SDN BHD LOT 12, MEDAN TASEK, TASEK INDUSTRIAL ESTATE IPOH PERAK 31400 MY Other 510(k) Applications for this Company
Contact	LEE SON HONG 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	11/10/2003
Decision Date	01/28/2004
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