FDA 510(k) Application Details - K213076

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K213076
Device Name	Patient Examination Glove, Specialty
Applicant	Aspen Glove Sdn. Bhd. Aspen House, 300, JLN Macalister, Georgetown 10450 MY Other 510(k) Applications for this Company
Contact	Iskandar Basha Bin Abdul Kadir Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2021
Decision Date	12/20/2021
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