FDA 510(k) Application Details - K231029

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K231029
Device Name	Polymer Patient Examination Glove
Applicant	Zhonghong Pulin Medical Products Co.,Ltd. West Industrial Park, Luannan County Tangshan 063500 CN Other 510(k) Applications for this Company
Contact	Li Yunjiao 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	04/11/2023
Decision Date	10/30/2023
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