Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K171104 |
Device Name |
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) |
Applicant |
YTY INDUSTRY (MANJUNG) SDN BHD |
Lot 1422-1424, Batu 10 Lekir |
Sitiawan,
MY
32020
|
|
Applicant Contact |
Punitha Samy |
Correspondent |
YTY INDUSTRY (MANJUNG) SDN BHD |
Lot 1422-1424, Batu 10 Lekir |
Sitiawan,
MY
32020
|
|
Correspondent Contact |
Punitha Samy |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 04/13/2017 |
Decision Date | 08/25/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|