Device Classification Name |
latex patient examination glove
|
510(k) Number |
K891272 |
Device Name |
'QUEST', 'PELANGI' PATIENT EXAM GLOVES (LATEX) |
Applicant |
PELANGI RUBBER PRODUCTS SDN. BHD. |
MLO LOT 2568, BATU 6, JALAN |
SKUDAI, 81200 JOHOR BAHRU |
NEGERI JOHOR DARUL TAKZIM,
MY
|
|
Applicant Contact |
JIT SOUN |
Correspondent |
PELANGI RUBBER PRODUCTS SDN. BHD. |
MLO LOT 2568, BATU 6, JALAN |
SKUDAI, 81200 JOHOR BAHRU |
NEGERI JOHOR DARUL TAKZIM,
MY
|
|
Correspondent Contact |
JIT SOUN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/09/1989 |
Decision Date | 04/26/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|