FDA 510(k) Application Details - K002314

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K002314
Device Name	Latex Patient Examination Glove
Applicant	PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT SELANGOR 41720 MY Other 510(k) Applications for this Company
Contact	TAN KONG CHANG 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	07/31/2000
Decision Date	08/17/2000
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