FDA 510(k) Application Details - K983175

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K983175
Device Name	Latex Patient Examination Glove
Applicant	ULTRAWIN SDN BHD LOT 2, PESIARAN PERINDUSTRIAN KANTHAN 2 CHEMOR, PERAK 31200 MY Other 510(k) Applications for this Company
Contact	SIEW HOE MAH 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	09/10/1998
Decision Date	10/13/1998
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