FDA 510(k) Application Details - K223320

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K223320
Device Name	Polymer Patient Examination Glove
Applicant	Lingshi Hongruida Health Protection Technology Co., Ltd. Yangjiayuan, Liangdu Town, Lingshi County Jinzhong 031300 CN Other 510(k) Applications for this Company
Contact	Yin Hongmei 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	10/28/2022
Decision Date	11/02/2022
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