Medical Device Manufacturer · US , Seattle , WA

Sime Health, Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1991

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sime Health, Ltd. General Hospital ✕

6 devices

1-6 of 6

Cleared Nov 15, 1995

SIME SURGICAL POWDERFREE

General Hospital · 79d

Cleared Nov 15, 1995

SIME POWDERFREE PLUS

General Hospital · 78d

Cleared May 09, 1994

SIME SURGICAL LATEX GLOVE

General Hospital · 76d

Cleared Oct 15, 1993

SIME HEALTH SIME HYPOALLERGENIC

General Hospital · 204d

Cleared Dec 04, 1992

SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES

General Hospital · 437d

Cleared Sep 19, 1991

General Hospital · 72d