Medical Device Manufacturer · MY , Malaysia

Ultrawin Sdn Bhd - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1992

Recent clearances: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE, EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ultrawin Sdn Bhd General Hospital ✕

5 devices

1-5 of 5

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

General Hospital · 65d