Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K180381 |
Device Name |
Powder Free Vinyl Patient Examination Gloves |
Applicant |
Shanxi Hongjin Plastic Technology Co., Ltd |
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County |
Linfen City,
CN
042399
|
|
Applicant Contact |
Wu Zhigang |
Correspondent |
Hongray USA Medical Products Inc |
3973 Schaefer Ave. |
Chino,
CA
91710
|
|
Correspondent Contact |
Kathy Liu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/12/2018 |
Decision Date | 11/07/2018 |
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
|
|
|