FDA 510(k) Application Details - K972615

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K972615
Device Name	Latex Patient Examination Glove
Applicant	WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI, SEPANG SELANGOR 43900 MY Other 510(k) Applications for this Company
Contact	CHOW YUE WAH 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	07/14/1997
Decision Date	01/26/1999
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