FDA 510(k) Application Details - K213075

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213075
Device Name	Polymer Patient Examination Glove
Applicant	Thai Rubber Gloves Co., Ltd. 680 Moo 2 Banbueng-Klaeng Rd. Nongyai 20190 TH Other 510(k) Applications for this Company
Contact	Chalongkwan Wongsasuthikul 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	09/23/2021
Decision Date	01/20/2022
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