FDA 510(k) Application Details - K001327

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K001327
Device Name	Latex Patient Examination Glove
Applicant	PREMIER PATHWAY SDN. BHD. 198 AVENUE DE LA D'EMERALD SPARKS, NV 89430-9550 US Other 510(k) Applications for this Company
Contact	JANNA P TUCKER 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	04/26/2000
Decision Date	05/23/2000
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