FDA 510(k) Application Details - K250944

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K250944
Device Name	Polymer Patient Examination Glove
Applicant	GMP Medicare Sdn. Bhd. Lot/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur Klang 41050 MY Other 510(k) Applications for this Company
Contact	Ummi Salmah Othman 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	03/28/2025
Decision Date	04/23/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review