FDA 510(k) Application Details - K203512

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K203512
Device Name	Polymer Patient Examination Glove
Applicant	VIP Glove SDN BHD No 17, Jalan Perusahaan 1, Kawasan Perusahaan Beranang Beranang 43700 MY Other 510(k) Applications for this Company
Contact	Terence Lim 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	11/30/2020
Decision Date	04/26/2021
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