FDA 510(k) Application Details - K223298

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K223298
Device Name	Latex Patient Examination Glove
Applicant	Shandong Intco Medical Products Co, Ltd. 9888 Qiwang Road, Naoshan Industrial Park Qingzhou 2625000 CN Other 510(k) Applications for this Company
Contact	Min Gao Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2022
Decision Date	02/22/2023
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