FDA 510(k) Application Details - K243959

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K243959
Device Name	Patient Examination Glove, Specialty
Applicant	Lingshi Hongruida Health Protection Technology Co., Ltd. Yangjiayuan, Liangdu Town, Lingshi County Jinzhong 031300 CN Other 510(k) Applications for this Company
Contact	Chai Tinglong Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	02/24/2025
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