Ultrawin Sdn Bhd is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Ultrawin Sdn Bhd - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Ultrawin Sdn Bhd has 5 FDA 510(k) cleared medical devices. Based in Malaysia, MY.
Historical record: 5 cleared submissions from 1992 to 2009. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Ultrawin Sdn Bhd Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ultrawin Sdn Bhd
5 devices
Cleared
Jul 28, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
General Hospital
124d
Cleared
Feb 29, 2008
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
General Hospital
151d
Cleared
Sep 24, 1999
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
General Hospital
88d
Cleared
Oct 13, 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
General Hospital
33d
Cleared
Mar 11, 1992
ULTRASAFE
General Hospital
65d