Device Classification Name |
latex patient examination glove
|
510(k) Number |
K222612 |
Device Name |
Powder-Free Latex examination gloves |
Applicant |
Guangdong Kingfa Sci.&Tech. Co., Ltd. |
No.28, Delong Ave., Shijiao Town, Qingcheng District |
Qingyuan,
CN
511545
|
|
Applicant Contact |
Xiaoge Yu |
Correspondent |
Guangdong Kingfa Sci.& Tech.Co., Ltd. |
No.28, Delong Ave., Shijiao Town, Qingcheng District |
Qingyuan,
CN
511545
|
|
Correspondent Contact |
Xiaoge Yu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/30/2022 |
Decision Date | 11/25/2022 |
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
|
|
|