FDA 510(k) Application Details - K243694

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K243694
Device Name	Polymer Patient Examination Glove
Applicant	Mah Sing Healthcare Sdn. Bhd. Lot 6478, Lorong Sungai Puloh/KU6, Kawasan Industri Sungai Puloh, Klang 42100 MY Other 510(k) Applications for this Company
Contact	Ivan Tan Chee Wei 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	11/29/2024
Decision Date	06/06/2025
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