FDA 510(k) Application Details - K201857

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K201857
Device Name	Polymer Patient Examination Glove
Applicant	Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban 70450 MY Other 510(k) Applications for this Company
Contact	Lim Kwee Shyan 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	07/06/2020
Decision Date	08/20/2021
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