Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K211808 |
Device Name |
Medcare Powder-Free Blue Nitrile Patient Examination Gloves |
Applicant |
Dongguan Grinvald Technology Co., Ltd. |
401, Building #3 No 4 of Guangming New Village 2 Road |
Dongcheng |
Dongguan,
CN
52300
|
|
Applicant Contact |
Anna Roxana Grinvald |
Correspondent |
mdi Consultants, Inc. |
55 Northern Blvd |
Great Neck,
NY
11021
|
|
Correspondent Contact |
Aristotle Nafpliotis |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/11/2021 |
Decision Date | 03/04/2022 |
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
|
|
|