Device Classification Name |
latex patient examination glove
|
510(k) Number |
K991743 |
Device Name |
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O |
Applicant |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
P.O. BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E. J. SMITH |
Correspondent |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
P.O. BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
E. J. SMITH |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/21/1999 |
Decision Date | 06/23/1999 |
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
|