FDA 510(k) Application Details - K223281

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K223281
Device Name	Polymer Patient Examination Glove
Applicant	Anhui Kindguard Medical Supplies Technology Co., Ltd Southwest of Intersection of Tonghe RD & HWY 343, The Economic Dvpt. Zone, Si County Suzhou 234300 CN Other 510(k) Applications for this Company
Contact	Guo Hua 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	10/25/2022
Decision Date	12/07/2022
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