Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K213058 |
Device Name |
O'Star Nitrile Examination Gloves Powder Free |
Applicant |
Star Investment And Trade Joint Stock Company |
Khac Niem Industrial Cluster, Khac Niem Ward |
Bac Ninh,
VN
16000
|
|
Applicant Contact |
Do Van Binh |
Correspondent |
Liberty Management Group Limited |
75 Executive Drive, Suite 114 |
Aurora,
IL
60504
|
|
Correspondent Contact |
Manoj Zacharias |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/22/2021 |
Decision Date | 02/08/2022 |
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
|
|
|