FDA 510(k) Application Details - K182600

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K182600
Device Name	Polymer Patient Examination Glove
Applicant	Better Care Plastic Technology Co., Ltd Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County Shenze County 050000 CN Other 510(k) Applications for this Company
Contact	Zhu Chuyan 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	09/21/2018
Decision Date	11/30/2018
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