FDA 510(k) Application Details - K091965

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K091965
Device Name	Polymer Patient Examination Glove
Applicant	PLATINUM GLOVE INDUSTRIES SDN.BHD. 18-2-2 JALAN SETIA PRIMA (Q) U13/Q, SETIA ALAM U13 SHAH ALAM, SELANGOR 40170 MY Other 510(k) Applications for this Company
Contact	SO SOON CHEAW Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2009
Decision Date	11/24/2009
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