FDA 510(k) Application Details - K212436

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K212436
Device Name	Vinyl Patient Examination Glove
Applicant	Shandong Langtai International Trade Co., Ltd. 8/F,office Building,Weiqiao Aluminum Deep Processing Industrial Park ,Chanshan Town,Zouping Binzhou 256206 CN Other 510(k) Applications for this Company
Contact	Ping Wang Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2021
Decision Date	12/23/2021
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