FDA 510(k) Application Details - K011995

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011995
Device Name	Latex Patient Examination Glove
Applicant	QUALITY LATEX PRODUCTS MALAYSIA SDN BHD 18-20, JALAN KILANG 2 JELAPANG LIGHT INDUST. ESTATE IPOH. PERAK 30100 MY Other 510(k) Applications for this Company
Contact	SHARENE WAN 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	06/26/2001
Decision Date	07/31/2001
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