FDA 510(k) Application Details - K211515

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K211515
Device Name	Polymer Patient Examination Glove
Applicant	Beijing Reagent Latex Products Co., Ltd. No. 6 Xingguang 5th Street, Opto-Mechatronics Industrial Park, Beishenshu Village East, Taihu Tn Beijing 101111 CN Other 510(k) Applications for this Company
Contact	HaiTao Liu 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	05/17/2021
Decision Date	08/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review