FDA 510(k) Application Details - K991744

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K991744
Device Name	Polymer Patient Examination Glove
Applicant	SHIELD GLOVES MANUFACTURER (M) SDN BHD P.O. BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E. J. SMITH 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	05/21/1999
Decision Date	06/23/1999
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