Device Classification Name |
surgeon's gloves
|
510(k) Number |
K171276 |
Device Name |
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs |
Applicant |
TG Medical SDN. BHD. |
Lot 5091, Jalan Teratai |
Batu 5, Off Jalan Meru |
Klang,
MY
41050
|
|
Applicant Contact |
Fatima Wati BT Mohamad |
Correspondent |
TG Medical SDN. BHD. |
Lot 5091, Jalan Teratai |
Batu 5, Off Jalan Meru |
Klang,
MY
41050
|
|
Correspondent Contact |
Fatima Wati BT Mohamad |
Regulation Number | 878.4460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/01/2017 |
Decision Date | 08/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|