Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K241252 |
Device Name |
Disposable Vinyl Examination Gloves |
Applicant |
Anqing Pukang Medical Technology Co., LTD. |
No 7 Haian Road |
Anqing,
CN
246000
|
|
Applicant Contact |
Min Gao |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/03/2024 |
Decision Date | 05/20/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|