FDA 510(k) Application Details - K163146

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K163146
Device Name	Patient Examination Glove, Specialty
Applicant	HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD ESTERN INDUSTRIAL ZONE NANGONG 051800 CN Other 510(k) Applications for this Company
Contact	Shaozhang Nan Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2016
Decision Date	02/13/2017
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