Device Classification Name |
latex patient examination glove
|
510(k) Number |
K002065 |
Device Name |
PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR |
Applicant |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
LOT 821, JALAN MATANG |
TAIPING, PERAK DARUL RIDZUAN,
MY
34750
|
|
Applicant Contact |
CHEE Y FOO |
Correspondent |
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD |
LOT 821, JALAN MATANG |
TAIPING, PERAK DARUL RIDZUAN,
MY
34750
|
|
Correspondent Contact |
CHEE Y FOO |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/07/2000 |
Decision Date | 08/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|