FDA 510(k) Application Details - K100162

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K100162
Device Name	Polymer Patient Examination Glove
Applicant	BIOGREEN YIELDS SDN.BHD LOT 1422, BATU 10 LEKIR SITIAWAN, PERAK 32020 MY Other 510(k) Applications for this Company
Contact	TIONG CHIONG KIENG 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	01/20/2010
Decision Date	03/24/2010
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