Medical Device Manufacturer · ID , Morawa, Sumut

Pt Mahakarya Inti Buana - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2005

Recent clearances: SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE), BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE, SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Aug 12, 2011

SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN,...

General Hospital · 95d

Cleared Apr 23, 2009

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE

General Hospital · 59d

Cleared Mar 15, 2007

SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

General Hospital · 105d

Cleared Nov 30, 2006

SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE

General Hospital · 114d

Cleared Nov 03, 2006

SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE

General Hospital · 185d

Cleared Jun 02, 2006

SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE

General Hospital · 186d

Cleared Mar 30, 2006

NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE

General Hospital · 115d

Cleared Feb 13, 2006

POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE

General Hospital · 70d

Cleared Sep 30, 2005

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

General Hospital · 39d