FDA 510(k) Application Details - K222129

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K222129
Device Name	Polymer Patient Examination Glove
Applicant	Top Glove Medical (Thailand) Co., Ltd. 188, 189, 190 Moo 5 Kanchanawanich Rd., Tambol Sumnakkhan Amphur Sadao 90320 TH Other 510(k) Applications for this Company
Contact	Shahana Parveen Binti Ridzam Shah 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	07/18/2022
Decision Date	02/10/2023
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