FDA 510(k) Application Details - K001485

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K001485
Device Name	Latex Patient Examination Glove
Applicant	PWA INDUSTRIES SDN. BHD. LOT 93, SEMAMBU INDUST. ESTATE KUANTAN, PAHANG 25350 MY Other 510(k) Applications for this Company
Contact	AZHARSYAH M YASSIN 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	05/12/2000
Decision Date	06/13/2000
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