Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K994222 |
Device Name |
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
Applicant |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
NO. 135 XIN-HUA WEST RD. |
SHIJIAZHUANG,
CN
050081
|
|
Applicant Contact |
GUI-XI LIU |
Correspondent |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
NO. 135 XIN-HUA WEST RD. |
SHIJIAZHUANG,
CN
050081
|
|
Correspondent Contact |
GUI-XI LIU |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/15/1999 |
Decision Date | 02/07/2000 |
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
|
|
|