Medical Device Manufacturer · IO , Lampung 35001-Iodonesia

Pt. Sarana Indoprotex - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1992

Recent clearances: LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE), POWDER-FREE EXAM GLOVES, ANDAL

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pt. Sarana Indoprotex General Hospital ✕

4 devices

1-4 of 4

Cleared Apr 14, 1998

LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)

General Hospital · 56d

Cleared Dec 04, 1997

POWDER-FREE EXAM GLOVES

General Hospital · 275d

Cleared May 10, 1995

General Hospital · 76d

Cleared Jan 07, 1992

PATIENT EXAMINATION GLOVEWS

General Hospital · 152d