FDA 510(k) Application Details - K993529

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K993529
Device Name	Latex Patient Examination Glove
Applicant	BIOGRAFIK (MALAYSIA) SDN BHD PT 3307 JALAN AM 1 ARAB-MALAYSIAN INDUSTRIAL PARK NILAI, NEGERI SEMBILAN 71800 MY Other 510(k) Applications for this Company
Contact	SHUKUR BIN HASRAN 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	10/18/1999
Decision Date	12/29/1999
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