FDA 510(k) Application Details - K210656

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K210656
Device Name	Surgeon'S Gloves
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	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2021
Decision Date	06/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review