Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K003133 |
Device Name |
MULTIPLE-VINYL EXAM GLOVE, POWDERED |
Applicant |
EXCELLENCE ENT. CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434 -9550
|
|
Applicant Contact |
JANNA P TUCKER |
Correspondent |
EXCELLENCE ENT. CO., LTD. |
198 AVENUE DE LA D'EMERALD |
SPARKS,
NV
89434 -9550
|
|
Correspondent Contact |
JANNA P TUCKER |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/06/2000 |
Decision Date | 11/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|