FDA 510(k) Application Details - K050530

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K050530
Device Name	Polymer Patient Examination Glove
Applicant	SPI GLOVES SDN. BHD. 5, PERSIARAN GREENTOWN 8 GREENTOWN BUSINESS CENTER IPOH 30450 MY Other 510(k) Applications for this Company
Contact	CHOOI FONG CHUN Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2005
Decision Date	03/16/2005
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