| Device Classification Name |
Latex Patient Examination Glove
|
| 510(k) Number |
K892470 |
| Device Name |
PATIENT EXAMINATION GLOVES (LATEX) |
| Applicant |
| Moore Medical Corp. |
| 80 Lebuh Raya Kapal |
| Off Jalan Chain Ferry, 12100 |
|
Butterworth, Penang.,
MY
|
|
| Applicant Contact |
KHENG LIAT |
| Correspondent |
| Moore Medical Corp. |
| 80 Lebuh Raya Kapal |
| Off Jalan Chain Ferry, 12100 |
|
Butterworth, Penang.,
MY
|
|
| Correspondent Contact |
KHENG LIAT |
| Regulation Number | 880.6250 |
| Classification Product Code |
|
| Date Received | 04/07/1989 |
| Decision Date | 07/14/1989 |
| 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
|
|
|