Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K001155 |
Device Name |
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR |
Applicant |
SHEEN MORE ENT. CO., LTD. |
NO.16, TOU KUNG SIX RD. |
TOU-LIU EXPANDED INDUST. PARK |
TOU-LIU, YUN-LIN,
TW
|
|
Applicant Contact |
KEN HUANG |
Correspondent |
SHEEN MORE ENT. CO., LTD. |
NO.16, TOU KUNG SIX RD. |
TOU-LIU EXPANDED INDUST. PARK |
TOU-LIU, YUN-LIN,
TW
|
|
Correspondent Contact |
KEN HUANG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 05/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|