FDA 510(k) Application Details - K202419

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K202419
Device Name	Polymer Patient Examination Glove
Applicant	TK Hitech Technology Co., Ltd. 1/221 Venish Irish Iris Watcharaphol Road Tha Rang, Bangkok 10220 TH Other 510(k) Applications for this Company
Contact	Kanyapadsanan Suppipatthipbodee 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	08/24/2020
Decision Date	04/16/2021
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