FDA 510(k) Application Details - K014055

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K014055
Device Name	Latex Patient Examination Glove
Applicant	SEAL POLYMER INDUSTRIES BHD. LT 72706, JALAN LAHAT, KAWASAN PERINDUSTRIAN BUKIT MERAH LAHAT, IPOH, PERAK 31500 MY Other 510(k) Applications for this Company
Contact	CHUN C FONG 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	12/10/2001
Decision Date	01/28/2002
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