FDA 510(k) Application Details - K233740

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K233740
Device Name	Polymer Patient Examination Glove
Applicant	W.A. Rubbermate Co., Ltd. 4 Ramkhamhaeng 19 (Chareonploy) Huamark Bangkok 10240 TH Other 510(k) Applications for this Company
Contact	Prachai Kongwaree 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	11/22/2023
Decision Date	02/13/2024
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