FDA 510(k) Application Details - K011012

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K011012
Device Name	Polymer Patient Examination Glove
Applicant	CONTRACT LATEX DIPPERS SDN BHD LOT 5B, 7A & 8A FASA 2 KAWASAN MIEL BATANG KALI, SELANGOR 44300 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	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2001
Decision Date	05/01/2001
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