Medical Device Manufacturer · US , Canton , OH

Omnigrace , Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1997

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omnigrace , Ltd. General Hospital ✕

8 devices

1-8 of 8

Cleared Jan 31, 2000

OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

General Hospital · 46d

Cleared Nov 19, 1999

OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE

General Hospital · 38d

Cleared Nov 09, 1999

OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

General Hospital · 60d

Cleared Aug 05, 1999

PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.

General Hospital · 69d

Cleared Aug 05, 1999

PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE

General Hospital · 69d

Cleared Dec 11, 1998

OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE

General Hospital · 50d

Cleared Dec 07, 1998

OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE

General Hospital · 46d

Cleared Nov 06, 1997

OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED

General Hospital · 77d