FDA 510(k) Application Details - K961675

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K961675
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	A K WONG 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	04/26/1996
Decision Date	07/25/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review