FDA 510(k) Application Details - K250342

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K250342
Device Name	Polymer Patient Examination Glove
Applicant	Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q, Kertih Bio-Polymer Park Kemaman 24300 MY Other 510(k) Applications for this Company
Contact	Atikah Muhyiddin 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	02/06/2025
Decision Date	07/08/2025
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