FDA 510(k) Application Details - K022572

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K022572
Device Name	Polymer Patient Examination Glove
Applicant	AR ALLIANCE HEALTHCARE SDN. BHD. 8, LORONG IND. 11, KAWASAN PERINDUSTRIAN BUKIT PANCHOR, NIBONG TEBAL, PULAU PINANG 14300 MY Other 510(k) Applications for this Company
Contact	CHUA C CHUAN 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	08/02/2002
Decision Date	11/08/2002
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