Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K024081 |
Device Name |
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
Applicant |
SAFEHEALTH MEDICAL SUPPLY CORP. |
NO. 1,TOU KANG LI, |
HSUEH CHIA COUNTY |
TAINAN HSIEN,
TW
|
|
Applicant Contact |
P.M. YEH |
Correspondent |
SAFEHEALTH MEDICAL SUPPLY CORP. |
NO. 1,TOU KANG LI, |
HSUEH CHIA COUNTY |
TAINAN HSIEN,
TW
|
|
Correspondent Contact |
P.M. YEH |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 12/11/2002 |
Decision Date | 01/28/2003 |
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
|
|
|