Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K190080 |
Device Name |
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) |
Applicant |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Lot 821, Jalan Matang |
Matang,
MY
34750
|
|
Applicant Contact |
Chan Yew Men |
Correspondent |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Lot 821, Jalan Matang |
Matang,
MY
34750
|
|
Correspondent Contact |
Chan Yew Men |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/16/2019 |
Decision Date | 06/27/2019 |
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
|
|
|