Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K964321 |
Device Name |
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) |
Applicant |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
NO. 135 XIN-HUA WEST RD. |
SHIJIAZHUANG,
CN
|
|
Applicant Contact |
LIN CHIN YU |
Correspondent |
SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. |
NO. 135 XIN-HUA WEST RD. |
SHIJIAZHUANG,
CN
|
|
Correspondent Contact |
LIN CHIN YU |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/29/1996 |
Decision Date | 01/09/1997 |
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
|
|
|