Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K211479 |
Device Name |
Blue Nitrile Examination Glove Powder Free |
Applicant |
Aspen Glove Sdn. Bhd. |
Aspen House, 300, JLN Macalister, |
Georgetown,
MY
10450
|
|
Applicant Contact |
Iskandar Basha bin Abdul Kadir |
Correspondent |
Liberty Management Group Ltd. |
75 Executive Dr. STE 114 |
Aurora,
IL
60504
|
|
Correspondent Contact |
Manoj Zacharias |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/12/2021 |
Decision Date | 09/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|