FDA 510(k) Application Details - K102189

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K102189
Device Name	Patient Examination Glove, Specialty
Applicant	LATEXX MANUFACTURING SDN.BHD. 11925 W 1-70 FRONTAGE RD NORTH, SUITE 900 WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	NEIL BURRIS Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2010
Decision Date	03/14/2012
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