Medical Device Manufacturer · ID , Medan

Pt. Mandiri Inti Buana - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE, FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE, FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pt. Mandiri Inti Buana General Hospital ✕

4 devices

1-4 of 4

Cleared Oct 06, 2005

FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

General Hospital · 76d

Cleared Dec 16, 2004

FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE

General Hospital · 120d

Cleared Jun 30, 2003

FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE

General Hospital · 91d

Cleared May 21, 2003

FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

General Hospital · 51d