FDA 510(k) Application Details - K210369

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K210369
Device Name	Polymer Patient Examination Glove
Applicant	Pastel Glove Sdn Bhd PT285724, Jalan Pusing, Taman Perindustrian Perabot Negeri Park Pusing 31550 MY Other 510(k) Applications for this Company
Contact	Siou Wei Law 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	02/08/2021
Decision Date	05/13/2021
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