FDA 510(k) Application Details - K002114

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K002114
Device Name	Latex Patient Examination Glove
Applicant	PERUSAHAAN PELINDUNG GETAH (M) SDN BHD EMPAT, SENAWANG INDUSTRIAL ESTATE, 70450 SEREMBAN, NEGERI SEMBILAN DARUL KHUSUS MALAYSIA ML Other 510(k) Applications for this Company
Contact	PETER YEW NIENG CHOON 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	07/12/2000
Decision Date	08/11/2000
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