FDA 510(k) Application Details - K221165

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221165
Device Name	Polymer Patient Examination Glove
Applicant	Sri Trang Gloves (Thailand) Public Company Limited 110 Kanjanavanit Road Hat Yai 80230 TH Other 510(k) Applications for this Company
Contact	Jordan Smith 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	04/22/2022
Decision Date	11/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review