FDA 510(k) Application Details - K954063

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K954063
Device Name	Latex Patient Examination Glove
Applicant	CONTRACT LATEX DIPPERS SDN BHD LOT 7A & 8A, KAWASAN MIEL, PHASE II, 44300 BATANG KALI SELANGOR, DARUL EHSAN MY Other 510(k) Applications for this Company
Contact	MOHAN 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	08/29/1995
Decision Date	06/05/1996
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