Medical Device Manufacturer · MY , Beranang, Selangor, D.E.

Perusahaan Intan Emas Sdn. Bhd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1989

Recent clearances: MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Perusahaan Intan Emas Sdn. Bhd. General Hospital ✕

4 devices

1-4 of 4

Cleared Oct 09, 1998

MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM...

General Hospital · 67d

Cleared Feb 02, 1994

MULTI-COMFORT POWDER FREE

General Hospital · 105d

Cleared Jul 06, 1993

HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES

General Hospital · 257d

Cleared Apr 28, 1989

PATIENT EXAMINATION GLOVES (LATEX)

General Hospital · 25d