FDA 510(k) Application Details - K102902

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K102902
Device Name	Latex Patient Examination Glove
Applicant	RUBBERCARE PROTECTION PRODUCTS SDN BHD OFF JALAN SENAWANG EMPAT SENAWANG INDUSTRIAL ESTATE SEREMBAN NEGERI SEMBILAN 70450 MY Other 510(k) Applications for this Company
Contact	LIM KWEE SHYAN 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	09/30/2010
Decision Date	04/22/2011
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