FDA 510(k) Application Details - K210868

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K210868
Device Name	Polymer Patient Examination Glove
Applicant	Great Eco Glove Sdn. Bhd. Lot 1675, Jalan Makmur, Batu 28, Ijok Bestari Jaya 45600 MY Other 510(k) Applications for this Company
Contact	Soh Wei Li 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	03/23/2021
Decision Date	09/02/2021
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