Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K202086 |
Device Name |
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors |
Applicant |
Shen Wei USA Inc. |
33278 Central Ave Ste 102 |
Union City,
CA
94587
|
|
Applicant Contact |
Cheryl Reep |
Correspondent |
Shen Wei USA Inc. |
33278 Central Ave Ste 102 |
Union City,
CA
94587
|
|
Correspondent Contact |
Cheryl Reep |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/27/2020 |
Decision Date | 03/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|