FDA 510(k) Application Details - K230958

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K230958
Device Name	Polymer Patient Examination Glove
Applicant	First Glove Sdn. Bhd. Unit 23-2, Level 23, Binjai 8, No. 2, Lorong Binjai Kuala Lumpur 50450 MY Other 510(k) Applications for this Company
Contact	Dean Segal 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	04/04/2023
Decision Date	05/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review