FDA 510(k) Application Details - K232538

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K232538
Device Name	Polymer Patient Examination Glove
Applicant	WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang 43900 MY Other 510(k) Applications for this Company
Contact	Muhammad Ameer Arief Mohd Mujab 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	08/22/2023
Decision Date	11/17/2023
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