FDA 510(k) Application Details - K991779

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991779
Device Name	Polymer Patient Examination Glove
Applicant	SELTOM PACIFIC SDN. BHD. LOT 25, JALAN PJS 7/17 SUNWAY INDUSTRIAL PARK PETALING JAYA, SELANGOR 46150 MY Other 510(k) Applications for this Company
Contact	S. SEGARAN 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	05/25/1999
Decision Date	08/11/1999
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