FDA 510(k) Application Details - K151208

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K151208
Device Name	Polymer Patient Examination Glove
Applicant	VRG KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMLET, LAI HUNG COMMUNE BEN CAT DISTRICT, VN Other 510(k) Applications for this Company
Contact	PHAM NGOC THANH 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	05/06/2015
Decision Date	09/14/2015
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