Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K220066 |
Device Name |
Medical Nitrile Examination Gloves |
Applicant |
Hunan Zhenheyikang Medical Instrument Co., Ltd |
No.6 Building Jingxiang Energy,No.55 Xiaguang East Road, |
Gaoxin District |
Xiangtan,
CN
411100
|
|
Applicant Contact |
Yilin Yin |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
RM. 1801, No. 161 Lujiazui East Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/10/2022 |
Decision Date | 04/03/2022 |
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
|
|
|