Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K010198 |
Device Name |
STERILE POWDERED LATEX SURGEON GLOVES |
Applicant |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
47000 SUNGAI BULOH |
SELANGOR,
MY
|
|
Applicant Contact |
STANLEY THAI |
Correspondent |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
47000 SUNGAI BULOH |
SELANGOR,
MY
|
|
Correspondent Contact |
STANLEY THAI |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 01/22/2001 |
Decision Date | 02/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|