FDA 510(k) Application Details - K210276

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K210276
Device Name	Polymer Patient Examination Glove
Applicant	Fujian Ercon Medical Management Co., Ltd. Unit 701, Xinyi International Center, No.3911 Huandao East Road, Siming District Xiamen 361000 CN Other 510(k) Applications for this Company
Contact	Lin Ruijin 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	02/01/2021
Decision Date	04/16/2021
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