FDA 510(k) Application Details - K230779

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K230779
Device Name	Polymer Patient Examination Glove
Applicant	Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Linfen 042300 CN Other 510(k) Applications for this Company
Contact	Wu Zhigang 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	03/21/2023
Decision Date	06/09/2023
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