Medical Device Manufacturer · ID , Tg Morawa-Deli Serdang Utara

Pt. Smartglove Indonesia - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2003

Recent clearances: POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES, POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pt. Smartglove Indonesia General Hospital ✕

12 devices

1-12 of 12

Cleared Jul 18, 2014

POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES

General Hospital · 227d

Cleared Sep 07, 2010

POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH...

General Hospital · 89d

Cleared Jul 01, 2010

POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...

General Hospital · 52d

Cleared Oct 19, 2009

POWDER FREE NITRILE EXAMINATION GLOVES, BLACK

General Hospital · 105d

Cleared Aug 20, 2004

POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR

General Hospital · 43d

Cleared Aug 12, 2004

POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)

General Hospital · 136d

Cleared Jun 03, 2004

POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

General Hospital · 66d

Cleared Mar 25, 2003

POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)

General Hospital · 57d

Cleared Feb 27, 2003

POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50...

General Hospital · 45d

Cleared Feb 27, 2003

NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR

General Hospital · 20d

Cleared Feb 19, 2003

MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)

General Hospital · 177d

Cleared Feb 13, 2003

MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX

General Hospital · 171d