FDA 510(k) Application Details - K233990

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K233990
Device Name	Polymer Patient Examination Glove
Applicant	Shandong Xingyu Gloves Co., Ltd. No. 2158 Yaoqian Road, Economic Development Zone Gaomi CN Other 510(k) Applications for this Company
Contact	Carrie Lee 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	12/18/2023
Decision Date	04/01/2024
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	N
Expedited Review