FDA 510(k) Application Details - K042101

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K042101
Device Name	Polymer Patient Examination Glove
Applicant	SEAL POLYMER INDUSTRIES BHD. LOT 72706,JALAN LAHAT, KAWASAN PERINDUSTRIAN BUKIT MERAH LAHAT, IPOH, PERAK 31500 MY Other 510(k) Applications for this Company
Contact	CHUN CHOOI FONG 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	08/04/2004
Decision Date	08/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review