| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K892365 |
| Device Name |
TA TA LATEX EXAM GLOVE |
| Applicant |
| Ta TA Industrial Co., Ltd. |
| # 269, An-Ho Rd. Sec. 2 |
|
Tainan,
TW
70901
|
|
| Applicant Contact |
RICK WANG |
| Correspondent |
| Ta TA Industrial Co., Ltd. |
| # 269, An-Ho Rd. Sec. 2 |
|
Tainan,
TW
70901
|
|
| Correspondent Contact |
RICK WANG |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 04/10/1989 |
| Decision Date | 04/26/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|