Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K220429 |
Device Name |
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile |
Applicant |
One Glove Industrial SDN BHD |
24, 1st floor, Kompleks Kota Mulia, Jalan Long Jaafar, |
Taiping,
MY
34000
|
|
Applicant Contact |
Marcus Low |
Correspondent |
Emergo Global Representative LLC, |
2500 Bee Cave Road, Building 1 Suite 300, |
Austin,
TX
78746
|
|
Correspondent Contact |
Michael Van Der Woude |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/15/2022 |
Decision Date | 05/13/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|