Medical Device Manufacturer · ML , 81700 Johor, Malaysia

Pan-Century Rubber Products Sdn. Bhd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1989

Recent clearances: POWDER FREE GLOVES (POLYMER COATED), POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM, POWDER FREE CHLORINATED GLOVES-(TEXTURED)

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pan-Century Rubber Products Sdn. Bhd. General Hospital ✕

9 devices

1-9 of 9

Cleared Nov 19, 1999

POWDER FREE GLOVES (POLYMER COATED)

General Hospital · 57d

Cleared Oct 29, 1999

POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...

General Hospital · 28d

Cleared Apr 23, 1998

POWDER FREE CHLORINATED GLOVES-(TEXTURED)

General Hospital · 23d

Cleared May 28, 1996

HIGH RISK GLOVES

General Hospital · 195d

Cleared Jan 27, 1993

HYPOALLERGENIC LATEX GLOVES

General Hospital · 141d

Cleared Jan 15, 1991

PATIENT EXAMINATION GLOVES-POWDER FREED

General Hospital · 11d

Cleared Jan 15, 1991

PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES

General Hospital · 11d

Cleared Jan 15, 1991

PATIENT EXAMINATION GLOVES-TEXTURED GLOVES

General Hospital · 11d

Cleared Sep 21, 1989

PATIENT EXAMINATION GLOVES

General Hospital · 66d