Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K011066 |
Device Name |
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) |
Applicant |
SMART GLOVE CORP. SDN BHD |
LOT 6487 BATU 5 3/4 |
JALAN KAPAR |
KLANG SELANGOR,
MY
42100
|
|
Applicant Contact |
NG-YEW SOON |
Correspondent |
SMART GLOVE CORP. SDN BHD |
LOT 6487 BATU 5 3/4 |
JALAN KAPAR |
KLANG SELANGOR,
MY
42100
|
|
Correspondent Contact |
NG-YEW SOON |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 04/09/2001 |
Decision Date | 09/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|