Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K222531 |
Device Name |
Synthetic Polymer Glove - Polyethylene (Black) |
Applicant |
UR Industry SDN BHD |
180, Jalan Murni 9, Taman Perindustrian Murni |
Senai,
MY
81400
|
|
Applicant Contact |
Chua Song Han |
Correspondent |
Integrated Assessment Services Pvt Ltd |
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, |
Chennai,
IN
600040
|
|
Correspondent Contact |
A.C. Thirumaran |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/22/2022 |
Decision Date | 01/22/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|