FDA 510(k) Application Details - K221773

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221773
Device Name	Polymer Patient Examination Glove
Applicant	ONETEXX SDN BHD No 73-86, JLN Logam 5, Perindustrian KMNTG 3 KMNTG Raya Ind Estate Kamunting 34600 MY Other 510(k) Applications for this Company
Contact	Freddy Low 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	06/21/2022
Decision Date	07/30/2022
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