FDA 510(k) Application Details - K244034

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K244034
Device Name	Polymer Patient Examination Glove
Applicant	Ever Global (Vietnam) Enterprise Corporation Long Thanh Industrial Zone Taman Village 810000 VN Other 510(k) Applications for this Company
Contact	Elizabeth Deng 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	12/30/2024
Decision Date	02/06/2025
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