Absolute Synthetic Technologies Malaysia Sdn. Bhd. is one of 96 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
Absolute Synthetic Technologies Malaysia Sdn. Bhd. - FDA 510(k) Clear...
Recent clearances: POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED), POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED), POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
3
Total
3
Cleared
0
Denied
Absolute Synthetic Technologies Malaysia Sdn. Bhd. has 3 FDA 510(k) cleared medical devices. Based in Kamunting, Taiping, Perak, MY.
Historical record: 3 cleared submissions from 1997 to 1997. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Absolute Synthetic Technologies Malaysia Sdn. Bhd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Absolute Synthetic Technologies Malaysia Sdn. Bhd.
3 devices
Cleared
Aug 15, 1997
POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE...
General Hospital
14d
Cleared
Jul 29, 1997
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
General Hospital
49d
Cleared
Jul 29, 1997
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
General Hospital
48d