FDA 510(k) Application Details - K230601

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K230601
Device Name	Polymer Patient Examination Glove
Applicant	Latrile Gloves Private Limited Plot No : B5 - Sipcot Induatrial Complex, 8th Main road, Pallapatti Village, Nilakottai Taluk Dindigul 624201 IN Other 510(k) Applications for this Company
Contact	M Ragu 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	03/03/2023
Decision Date	05/28/2023
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