Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K010663 |
Device Name |
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE |
Applicant |
TONG RUHN MEDICAL PRODUCTS CO., LTD. |
1202 S. RTE 31 |
MCHENRY,
IL
60050
|
|
Applicant Contact |
ANTONIO L GIACCIO |
Correspondent |
TONG RUHN MEDICAL PRODUCTS CO., LTD. |
1202 S. RTE 31 |
MCHENRY,
IL
60050
|
|
Correspondent Contact |
ANTONIO L GIACCIO |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/06/2001 |
Decision Date | 03/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|