FDA 510(k) Application Details - K203191

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K203191
Device Name	Polymer Patient Examination Glove
Applicant	Nathan Trading Co., Ltd 58 Moo 12 Palan Sub-District Nathan District 34170 TH Other 510(k) Applications for this Company
Contact	Chansamone Saiyasak 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	10/27/2020
Decision Date	02/12/2021
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	Y
Expedited Review