Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K992821 |
Device Name |
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
Applicant |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Applicant Contact |
KAREN ABELL |
Correspondent |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
KAREN ABELL |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/20/1999 |
Decision Date | 03/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|