FDA 510(k) Application Details - K213371

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213371
Device Name	Polymer Patient Examination Glove
Applicant	Anhui Xinyisheng Medical Technology Co.,Ltd No.999 North of the intersection of Tonghe Road and G343 Road Si County Suzhou 234000 CN Other 510(k) Applications for this Company
Contact	Shyla Tang 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	10/12/2021
Decision Date	12/09/2021
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	Y
Expedited Review