FDA 510(k) Application Details - K022659

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K022659
Device Name	Latex Patient Examination Glove
Applicant	PURNABINA SDN BHD PLO 5, JALAN MAHSURI 1, 7.5KM J. MERSING, KLUANG IND. AREA KLUANG, JOHOR D. TAKZIM 86000 MY Other 510(k) Applications for this Company
Contact	LIEW YOON 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	08/09/2002
Decision Date	09/25/2002
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