Medical Device Manufacturer · US , Great Neck, , NY

P.T. Saptindo Surgica - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1995

Recent clearances: STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING, STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING, MEDI PLUS SURGEON'S GLOVES

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - P.T. Saptindo Surgica General Hospital ✕

3 devices

1-3 of 3

Cleared Sep 23, 2003

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING

General Hospital · 117d

Cleared Sep 23, 2003

STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING

General Hospital · 117d

Cleared Mar 07, 1995

MEDI PLUS SURGEON'S GLOVES

General Hospital · 139d