FDA 510(k) Application Details - K992675

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K992675
Device Name	Polymer Patient Examination Glove
Applicant	WEAR SAFE MALAYSIA SDN. BHD. LOT 1, LEBOH HISHAMUDDIN SATU, NORTH KLANG STRAITS IND. AREA PORT KLANG, SELANGOR, D.E. 42000 MY Other 510(k) Applications for this Company
Contact	CLAUDE COTTET 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	08/10/1999
Decision Date	01/20/2000
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