FDA 510(k) Application Details - K242812

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K242812
Device Name	Polymer Patient Examination Glove
Applicant	NB MEDICAL COMPANY LIMITED Tay An Industrial Cluster, Tien Hai Town, Tien Hai District Thai Binh Province VN Other 510(k) Applications for this Company
Contact	Thi Vinh Vu 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	09/18/2024
Decision Date	10/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review