FDA 510(k) Application Details - K180381

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K180381
Device Name	Vinyl Patient Examination Glove
Applicant	Shanxi Hongjin Plastic Technology Co., Ltd Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Linfen City 042399 CN Other 510(k) Applications for this Company
Contact	Wu Zhigang 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	02/12/2018
Decision Date	11/07/2018
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