FDA 510(k) Application Details - K171460

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K171460
Device Name	Vinyl Patient Examination Glove
Applicant	Shandong Zhiwei Medical Products, Co. Ltd. No. 4519 Qingzhou Road Qingzhou 255000 CN Other 510(k) Applications for this Company
Contact	Carrie Wu Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2017
Decision Date	09/24/2017
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