Device Classification Name |
surgeon's gloves
|
510(k) Number |
K021159 |
Device Name |
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM |
Applicant |
WRP ASIA PACIFIC SDN. BHD. |
LOT1,JALAN3,KAWASAN PERUSAHAAN |
BANDAR BARU SALAK TINGGI |
SEPANG,SELANGOR DARUL EHSAN,
MY
43900
|
|
Applicant Contact |
K. K LEONG |
Correspondent |
WRP ASIA PACIFIC SDN. BHD. |
LOT1,JALAN3,KAWASAN PERUSAHAAN |
BANDAR BARU SALAK TINGGI |
SEPANG,SELANGOR DARUL EHSAN,
MY
43900
|
|
Correspondent Contact |
K. K LEONG |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 04/11/2002 |
Decision Date | 07/03/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|