FDA 510(k) Application Details - K983568

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K983568
Device Name	Latex Patient Examination Glove
Applicant	CONTRACT LATEX DIPPERS SDN BHD NO. 11-2ND FL. JALAN 7/70A SRI HARTAMAS KUALA LUMPUR 50480 MY Other 510(k) Applications for this Company
Contact	VINAYAGAN RAMALINGAM 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	10/13/1998
Decision Date	12/21/1998
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