FDA 510(k) Application Details - K222907

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K222907
Device Name	Polymer Patient Examination Glove
Applicant	RMKH Glove (Cambodia) Co., Ltd. Manhattan Special Economic Zone, Bavet Commune Bavet City 120407 KH Other 510(k) Applications for this Company
Contact	Yang Clement KC 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	09/26/2022
Decision Date	01/04/2023
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