Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K000166 |
Device Name |
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES |
Applicant |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
13945 MAGNOLIA AVE. |
CHINO,
CA
91710
|
|
Applicant Contact |
JAMES CHU |
Correspondent |
SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD |
13945 MAGNOLIA AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
JAMES CHU |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/19/2000 |
Decision Date | 02/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|