Encompass Industries Sdn. Bhd. is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Encompass Industries Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl, Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color), Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
3
Total
3
Cleared
0
Denied
Encompass Industries Sdn. Bhd. has 3 FDA 510(k) cleared medical devices. Based in Kemaman, MY.
Latest FDA clearance: Jul 2025. Active since 2019. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Encompass Industries Sdn. Bhd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Encompass Industries Sdn. Bhd.
3 devices
Cleared
Jul 08, 2025
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use...
General Hospital
152d
Cleared
May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs...
General Hospital
86d
Cleared
Oct 23, 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black...
General Hospital
307d