FDA 510(k) Application Details - K203702

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K203702
Device Name	Vinyl Patient Examination Glove
Applicant	Xinying Trading CO., LTD. Garden Street Dezhou 253000 CN Other 510(k) Applications for this Company
Contact	Tongguang Liu 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	12/18/2020
Decision Date	02/12/2021
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