Semperit Investments Asia Pte , Ltd. is one of 29 FDA 510(k) medical device manufacturers from Singapore in the dataset, ranked by real submission volume.
Semperit Investments Asia Pte , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102), Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
4
Total
4
Cleared
0
Denied
Semperit Investments Asia Pte , Ltd. has 4 FDA 510(k) cleared medical devices. Based in Singapore, SG.
Last cleared in 2023. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Semperit Investments Asia Pte , Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mansour Consulting, LLC and Mansour Company, LLC.
FDA 510(k) Regulatory Record - Semperit Investments Asia Pte , Ltd.
4 devices
Cleared
Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use...
General Hospital
30d
Cleared
Oct 04, 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile,...
General Hospital
296d
Cleared
Sep 14, 2017
Non-Sterile, Single use, Powder-free examination glove tested for use with...
General Hospital
127d
Cleared
May 02, 2017
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
General Hospital
406d