Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K212436 |
Device Name |
NBR Synthetic Nitrile Examination Gloves |
Applicant |
Shandong Langtai International Trade Co., Ltd. |
8/F,office Building,Weiqiao Aluminum Deep Processing |
Industrial Park ,Chanshan Town,Zouping |
Binzhou,
CN
256206
|
|
Applicant Contact |
Ping Wang |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
RM.1801,No.161,East Lujiazui Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 08/04/2021 |
Decision Date | 12/23/2021 |
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
|
|
|