FDA 510(k) Application Details - K232039

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K232039
Device Name	Polymer Patient Examination Glove
Applicant	Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang 050000 CN Other 510(k) Applications for this Company
Contact	Wu Yuli 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	07/10/2023
Decision Date	08/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review