Device Classification Name |
surgeon's gloves
|
510(k) Number |
K171279 |
Device Name |
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves |
Applicant |
Top Glove SDN BHD |
Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru |
Klang,
MY
41050
|
|
Applicant Contact |
Noor Akilah Bt Saidin |
Correspondent |
Top Glove SDN BHD |
Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru |
Klang,
MY
41050
|
|
Correspondent Contact |
Noor Akilah Bt Saidin |
Regulation Number | 878.4460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/01/2017 |
Decision Date | 10/12/2017 |
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
|
|
|