Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K992100 |
Device Name |
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED |
Applicant |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
#1 BIYU RD., CANGQIAO TOWNSHIP |
SONGJIANG SHANGHAI,
CN
|
|
Applicant Contact |
DANNY WANG |
Correspondent |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
#1 BIYU RD., CANGQIAO TOWNSHIP |
SONGJIANG SHANGHAI,
CN
|
|
Correspondent Contact |
DANNY WANG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/21/1999 |
Decision Date | 07/29/1999 |
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
|
|
|