Medical Device Manufacturer · MY , Selangor Darul Ehsan

Seltom Pacific Sdn. Bhd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1999

Recent clearances: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN), LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE), NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)

7

Total

7

Cleared

0

Denied

Seltom Pacific Sdn. Bhd. has 7 FDA 510(k) cleared medical devices. Based in Selangor Darul Ehsan, MY.

Historical record: 7 cleared submissions from 1999 to 2001. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by Seltom Pacific Sdn. Bhd. Filter by specialty or product code using the sidebar.

Seltom Pacific Sdn. Bhd. is one of 158 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Seltom Pacific Sdn. Bhd.

7 devices

1-7 of 7

Cleared Jul 10, 2001

POWDERED BLUE NITRILE EXAMINATION GLOVES

General Hospital · 20d

Cleared Jul 05, 2001

POWDERED LATEX EXAMINATION GLOVES

General Hospital · 15d

Cleared Jan 26, 2001

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200...

General Hospital · 37d

Cleared Aug 31, 1999

LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50...

General Hospital · 98d

Cleared Aug 31, 1999

LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)

General Hospital · 98d

Cleared Aug 11, 1999

NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)

General Hospital · 78d

Cleared Aug 11, 1999

NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)

General Hospital · 78d