FDA 510(k) Application Details - K171782

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K171782
Device Name	Polymer Patient Examination Glove
Applicant	Blue Sail Medical Co.,Ltd No. 21 Qingtian Road, Qilu Chemical Industrial Park Zibo 255414 CN Other 510(k) Applications for this Company
Contact	Robin Liu 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	06/15/2017
Decision Date	10/12/2017
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