Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K202010 |
Device Name |
Disposable Vinyl Glove |
Applicant |
Better Health Medical Products Co., Ltd. |
Zhangliu Road, Zhangdian District |
Zibo,
CN
255087
|
|
Applicant Contact |
Xiaomeng Li |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
Room608,No.738,Shangcheng Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/21/2020 |
Decision Date | 10/16/2020 |
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
|
|
|